Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
Ecri has received failure reports from the assembly equipment which result in the equipment collapse or in the injury / involvement of patients or team members. fault reports included cracking of arm bracket or bracket of bracket machine. ecri affirms that these faults of the mounting equipment are generally resulting from inadequate decisions of installation, defective equipment or lower quality, misuse of equipment or wear and normal break.
Acción
ECRI MAKES THE FOLLOWING RECOMMENDATIONS: (1) REPORT TO EMPLOYEES THAT ASSEMBLING EQUIPMENT MAY FAIL AND CAUSE CORPORATE INJURY (2) DEFINE WHICH DEPARTMENT SHALL BE RESPONSIBLE FOR ROUTINE INSPECTIONS AND PREVENTIVE MAINTENANCE, AND REPORT THE EVIDENCE OF DAMAGE TO ASSEMBLY EQUIPMENT A THIS DEPARTMENT. (3) REPORT TO EMPLOYEES THAT THE ASSEMBLY EQUIPMENT MAY BE DAMAGED BY ITS BRUSK / UNUSED USE AND THAT THIS MUST BE HANDLED AS CAREFULLY AS MUCH AS THE MEDICAL EQUIPMENT AFFECTED IN IT. (4) INSPECT THE INSTALLATION OF THE MOUNTING EQUIPMENT TO ENSURE THAT STRUCTURES AND SUITABLE COMPONENTS ARE USED. (5) TURN THE ASSEMBLY EQUIPMENT INSPECTION PART OF THE INSPECTION ROUTINE OF ITS INSTALLATIONS AND ITS PREVENTIVE MAINTENANCE PROGRAM
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
Ecri has received failure reports from the assembly equipment which result in the equipment collapse or in the injury / involvement of patients or team members. fault reports included cracking of arm bracket or bracket of bracket machine. ecri affirms that these faults of the mounting equipment are generally resulting from inadequate decisions of installation, defective equipment or lower quality, misuse of equipment or wear and normal break.
Acción
ECRI MAKES THE FOLLOWING RECOMMENDATIONS: (1) REPORT TO EMPLOYEES THAT ASSEMBLING EQUIPMENT MAY FAIL AND CAUSE CORPORATE INJURY (2) DEFINE WHICH DEPARTMENT SHALL BE RESPONSIBLE FOR ROUTINE INSPECTIONS AND PREVENTIVE MAINTENANCE, AND REPORT THE EVIDENCE OF DAMAGE TO ASSEMBLY EQUIPMENT A THIS DEPARTMENT. (3) REPORT TO EMPLOYEES THAT THE ASSEMBLY EQUIPMENT MAY BE DAMAGED BY ITS BRUSK / UNUSED USE AND THAT THIS MUST BE HANDLED AS CAREFULLY AS MUCH AS THE MEDICAL EQUIPMENT AFFECTED IN IT. (4) INSPECT THE INSTALLATION OF THE MOUNTING EQUIPMENT TO ENSURE THAT STRUCTURES AND SUITABLE COMPONENTS ARE USED. (5) TURN THE ASSEMBLY EQUIPMENT INSPECTION PART OF THE INSPECTION ROUTINE OF ITS INSTALLATIONS AND ITS PREVENTIVE MAINTENANCE PROGRAM
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
Ecri has received failure reports from the assembly equipment which result in the equipment collapse or in the injury / involvement of patients or team members. fault reports included cracking of arm bracket or bracket of bracket machine. ecri affirms that these faults of the mounting equipment are generally resulting from inadequate decisions of installation, defective equipment or lower quality, misuse of equipment or wear and normal break.
Acción
ECRI MAKES THE FOLLOWING RECOMMENDATIONS: (1) REPORT TO EMPLOYEES THAT ASSEMBLING EQUIPMENT MAY FAIL AND CAUSE CORPORATE INJURY (2) DEFINE WHICH DEPARTMENT SHALL BE RESPONSIBLE FOR ROUTINE INSPECTIONS AND PREVENTIVE MAINTENANCE, AND REPORT THE EVIDENCE OF DAMAGE TO ASSEMBLY EQUIPMENT A THIS DEPARTMENT. (3) REPORT TO EMPLOYEES THAT THE ASSEMBLY EQUIPMENT MAY BE DAMAGED BY ITS BRUSK / UNUSED USE AND THAT THIS MUST BE HANDLED AS CAREFULLY AS MUCH AS THE MEDICAL EQUIPMENT AFFECTED IN IT. (4) INSPECT THE INSTALLATION OF THE MOUNTING EQUIPMENT TO ENSURE THAT STRUCTURES AND SUITABLE COMPONENTS ARE USED. (5) TURN THE ASSEMBLY EQUIPMENT INSPECTION PART OF THE INSPECTION ROUTINE OF ITS INSTALLATIONS AND ITS PREVENTIVE MAINTENANCE PROGRAM
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
Ecri has received failure reports from the assembly equipment which result in the equipment collapse or in the injury / involvement of patients or team members. fault reports included cracking of arm bracket or bracket of bracket machine. ecri affirms that these faults of the mounting equipment are generally resulting from inadequate decisions of installation, defective equipment or lower quality, misuse of equipment or wear and normal break.
Acción
ECRI MAKES THE FOLLOWING RECOMMENDATIONS: (1) REPORT TO EMPLOYEES THAT ASSEMBLING EQUIPMENT MAY FAIL AND CAUSE CORPORATE INJURY (2) DEFINE WHICH DEPARTMENT SHALL BE RESPONSIBLE FOR ROUTINE INSPECTIONS AND PREVENTIVE MAINTENANCE, AND REPORT THE EVIDENCE OF DAMAGE TO ASSEMBLY EQUIPMENT A THIS DEPARTMENT. (3) REPORT TO EMPLOYEES THAT THE ASSEMBLY EQUIPMENT MAY BE DAMAGED BY ITS BRUSK / UNUSED USE AND THAT THIS MUST BE HANDLED AS CAREFULLY AS MUCH AS THE MEDICAL EQUIPMENT AFFECTED IN IT. (4) INSPECT THE INSTALLATION OF THE MOUNTING EQUIPMENT TO ENSURE THAT STRUCTURES AND SUITABLE COMPONENTS ARE USED. (5) TURN THE ASSEMBLY EQUIPMENT INSPECTION PART OF THE INSPECTION ROUTINE OF ITS INSTALLATIONS AND ITS PREVENTIVE MAINTENANCE PROGRAM
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
An ecri member hospital reported an incident in which a physiological monitor interfered on the wav potential evocado of an evolved electromiography / potential equipment (emg / ep).
Acción
TO REDUCE THE EMISSION OF ELECTROMAGNETIC INTERFERENCE, EMI, AND MINIMIZE THE EFFECTS OF EMISSIONS IN HOSPITAL EQUIPMENT, ECRI RECOMMENDS THAT THE FOLLOWING: (1) MAKE SURE THAT APPROPRIATE FILTER ASSEMBLIES ARE SELECTED FOR SENSITIVE RECORDING EQUIPMENT. (2) REMOVE SENSITIVE EQUIPMENT FROM THE NEARBY OF OTHER ELECTRONIC EQUIPMENT, WHEREVER IT IS POSSIBLE. (3) USE DIFFERENT EQUIPMENT, IF NECESSARY. ECRI RECOMMENDS THE ADOPTION OF THE FOLLOWING PROCEDURES IN EQUIPMENT WITH ELECTRODES, CONDUCTOR WIREs AND CABLES FOR MINIMIZING EMI EMISSIONS: (1) ENSURE THAT GOOD QUALITY ELECTRODES ARE USED AND THAT ARE PROPERLY POSTED TO THE PATIENT. (2) IF STIMULATION AND RECORDING ELECTRODES ARE USED SIMULTANEOUSLY, SEPARATE THE TWO TYPES OF ELECTRODES TO THE MAXIMUM POSSIBLE. (3) KEEP THE DRIVING WIRES ORIGINATED FROM A SINGLE SOURCE, WHETHER AN INDIVIDUAL EQUIPMENT, AS AN EMG, OR A COMPOUND, AS THE MONITORING MODULE, GROUPED TO THE LARGE EXTENT POSSIBLE TO MINIMIZE MAGNETIC AND ELECTRICAL DISTURBANCES. (4) WHEN POSSIBLE, DIRECT THE ORIGINATED WIRES OF DIFFERENT SOURCES FOR DIFFERENT DIRECTIONS AND AVOID THE WIRING OF WIRES OF DIFFERENT EQUIPMENT. TO REDUCE EMI EMISSIONS FROM THE ENERGY SOURCE OF THE EQUIPMENT, ECRI RECOMMENDS TO TAKE THE FOLLOWING PRECAUTIONS: (1) CONNECT MEDICAL EQUIPMENT TO TAKEN WITH PROPER LANDING; TEST DIFFERENT TAKES AND OBSERVE THE EFFECTS ON THE OPERATION OF THE EQUIPMENT. (2) IMPLEMENT AN ENERGY QUALITY PROGRAM IN PARTNERSHIP WITH THE ELECTRICITY COMPANIES, HOSPITAL OFFICIALS AND FINAL USERS TO MINIMIZE THE INTERFERENCE OF DRIVING CABLES AND ENERGY FREQUENCY. ECRI RECOMMENDS THAT YOU ALWAYS CONSIDER EMI AS A POTENTIAL SOURCE OF THE MALFUNCTIONING OF EQUIPMENT, ESPECIALLY WHEN THE READING OF THE EQUIPMENT SEEMS TO BE AFFECTED BY NOISE, SORRY OF THE EQUIPMENT BE DULY CONNECTED AND POSTED TO THE PATIENT. IF ANY EMI PROBLEMS ARE SUSPECTED, CHECK THE DOCUMENTATION OF ANY ELECTRONIC HOSPITAL EQUIPMENT THAT IS BEING USED IN THE AREA. WHEN YOU ARE VERIFYING THE DOCUMENTATION, ECRI RECOMMENDS YOU TO VERIFY: (1) IF THE EQUIPMENT IS CLASS A OR B, BECAUSE THE CLASS EQUIPMENT IS EMITTED TO GREATER ELECTROMAGNETIC ENERGY, AND (2) EMI'S SPECIFIC RECOMMENDATIONS FROM THE MANUFACTURER. ECRI RECOMMENDS THAT USERS AND CLINICAL ENGINEER EMPLOYEES SHOULD ALWAYS BE ALTHOUGH YOU HAVE EMI PROBLEMS. IN ADDITION, ECRI RECOMMENDS THAT EMPLOYEES SHALL BE INFORMED OF THE EFFECTS EMI MAY HAVE IN THE OPERATION OF EQUIPMENT AND RECOMMENDATIONS BY ECRI FOR THE REDUCTION OR DISPOSAL OF INTERFERENCE. FOR FURTHER INFORMATION REGARDING ECRI'S EMI RISK REPORT, CONTACT CARLOS FORNAZIER, AT THE ELECTRONIC MAIL TECNOVIGILANCIA@ANVISA.GOV.BR OR BY PHONE 0XX-61-4481331.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
An ecri member hospital reported an incident in which a physiological monitor interfered on the wav potential evocado of an evolved electromiography / potential equipment (emg / ep).
Acción
TO REDUCE THE EMISSION OF ELECTROMAGNETIC INTERFERENCE, EMI, AND MINIMIZE THE EFFECTS OF EMISSIONS IN HOSPITAL EQUIPMENT, ECRI RECOMMENDS THAT THE FOLLOWING: (1) MAKE SURE THAT APPROPRIATE FILTER ASSEMBLIES ARE SELECTED FOR SENSITIVE RECORDING EQUIPMENT. (2) REMOVE SENSITIVE EQUIPMENT FROM THE NEARBY OF OTHER ELECTRONIC EQUIPMENT, WHEREVER IT IS POSSIBLE. (3) USE DIFFERENT EQUIPMENT, IF NECESSARY. ECRI RECOMMENDS THE ADOPTION OF THE FOLLOWING PROCEDURES IN EQUIPMENT WITH ELECTRODES, CONDUCTOR WIREs AND CABLES FOR MINIMIZING EMI EMISSIONS: (1) ENSURE THAT GOOD QUALITY ELECTRODES ARE USED AND THAT ARE PROPERLY POSTED TO THE PATIENT. (2) IF STIMULATION AND RECORDING ELECTRODES ARE USED SIMULTANEOUSLY, SEPARATE THE TWO TYPES OF ELECTRODES TO THE MAXIMUM POSSIBLE. (3) KEEP THE DRIVING WIRES ORIGINATED FROM A SINGLE SOURCE, WHETHER AN INDIVIDUAL EQUIPMENT, AS AN EMG, OR A COMPOUND, AS THE MONITORING MODULE, GROUPED TO THE LARGE EXTENT POSSIBLE TO MINIMIZE MAGNETIC AND ELECTRICAL DISTURBANCES. (4) WHEN POSSIBLE, DIRECT THE ORIGINATED WIRES OF DIFFERENT SOURCES FOR DIFFERENT DIRECTIONS AND AVOID THE WIRING OF WIRES OF DIFFERENT EQUIPMENT. TO REDUCE EMI EMISSIONS FROM THE ENERGY SOURCE OF THE EQUIPMENT, ECRI RECOMMENDS TO TAKE THE FOLLOWING PRECAUTIONS: (1) CONNECT MEDICAL EQUIPMENT TO TAKEN WITH PROPER LANDING; TEST DIFFERENT TAKES AND OBSERVE THE EFFECTS ON THE OPERATION OF THE EQUIPMENT. (2) IMPLEMENT AN ENERGY QUALITY PROGRAM IN PARTNERSHIP WITH THE ELECTRICITY COMPANIES, HOSPITAL OFFICIALS AND FINAL USERS TO MINIMIZE THE INTERFERENCE OF DRIVING CABLES AND ENERGY FREQUENCY. ECRI RECOMMENDS THAT YOU ALWAYS CONSIDER EMI AS A POTENTIAL SOURCE OF THE MALFUNCTIONING OF EQUIPMENT, ESPECIALLY WHEN THE READING OF THE EQUIPMENT SEEMS TO BE AFFECTED BY NOISE, SORRY OF THE EQUIPMENT BE DULY CONNECTED AND POSTED TO THE PATIENT. IF ANY EMI PROBLEMS ARE SUSPECTED, CHECK THE DOCUMENTATION OF ANY ELECTRONIC HOSPITAL EQUIPMENT THAT IS BEING USED IN THE AREA. WHEN YOU ARE VERIFYING THE DOCUMENTATION, ECRI RECOMMENDS YOU TO VERIFY: (1) IF THE EQUIPMENT IS CLASS A OR B, BECAUSE THE CLASS EQUIPMENT IS EMITTED TO GREATER ELECTROMAGNETIC ENERGY, AND (2) EMI'S SPECIFIC RECOMMENDATIONS FROM THE MANUFACTURER. ECRI RECOMMENDS THAT USERS AND CLINICAL ENGINEER EMPLOYEES SHOULD ALWAYS BE ALTHOUGH YOU HAVE EMI PROBLEMS. IN ADDITION, ECRI RECOMMENDS THAT EMPLOYEES SHALL BE INFORMED OF THE EFFECTS EMI MAY HAVE IN THE OPERATION OF EQUIPMENT AND RECOMMENDATIONS BY ECRI FOR THE REDUCTION OR DISPOSAL OF INTERFERENCE. FOR FURTHER INFORMATION REGARDING ECRI'S EMI RISK REPORT, CONTACT CARLOS FORNAZIER, AT THE ELECTRONIC MAIL TECNOVIGILANCIA@ANVISA.GOV.BR OR BY PHONE 0XX-61-4481331.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
An ecri member hospital reported an incident in which a physiological monitor interfered on the wav potential evocado of an evolved electromiography / potential equipment (emg / ep).
Acción
TO REDUCE THE EMISSION OF ELECTROMAGNETIC INTERFERENCE, EMI, AND MINIMIZE THE EFFECTS OF EMISSIONS IN HOSPITAL EQUIPMENT, ECRI RECOMMENDS THAT THE FOLLOWING: (1) MAKE SURE THAT APPROPRIATE FILTER ASSEMBLIES ARE SELECTED FOR SENSITIVE RECORDING EQUIPMENT. (2) REMOVE SENSITIVE EQUIPMENT FROM THE NEARBY OF OTHER ELECTRONIC EQUIPMENT, WHEREVER IT IS POSSIBLE. (3) USE DIFFERENT EQUIPMENT, IF NECESSARY. ECRI RECOMMENDS THE ADOPTION OF THE FOLLOWING PROCEDURES IN EQUIPMENT WITH ELECTRODES, CONDUCTOR WIREs AND CABLES FOR MINIMIZING EMI EMISSIONS: (1) ENSURE THAT GOOD QUALITY ELECTRODES ARE USED AND THAT ARE PROPERLY POSTED TO THE PATIENT. (2) IF STIMULATION AND RECORDING ELECTRODES ARE USED SIMULTANEOUSLY, SEPARATE THE TWO TYPES OF ELECTRODES TO THE MAXIMUM POSSIBLE. (3) KEEP THE DRIVING WIRES ORIGINATED FROM A SINGLE SOURCE, WHETHER AN INDIVIDUAL EQUIPMENT, AS AN EMG, OR A COMPOUND, AS THE MONITORING MODULE, GROUPED TO THE LARGE EXTENT POSSIBLE TO MINIMIZE MAGNETIC AND ELECTRICAL DISTURBANCES. (4) WHEN POSSIBLE, DIRECT THE ORIGINATED WIRES OF DIFFERENT SOURCES FOR DIFFERENT DIRECTIONS AND AVOID THE WIRING OF WIRES OF DIFFERENT EQUIPMENT. TO REDUCE EMI EMISSIONS FROM THE ENERGY SOURCE OF THE EQUIPMENT, ECRI RECOMMENDS TO TAKE THE FOLLOWING PRECAUTIONS: (1) CONNECT MEDICAL EQUIPMENT TO TAKEN WITH PROPER LANDING; TEST DIFFERENT TAKES AND OBSERVE THE EFFECTS ON THE OPERATION OF THE EQUIPMENT. (2) IMPLEMENT AN ENERGY QUALITY PROGRAM IN PARTNERSHIP WITH THE ELECTRICITY COMPANIES, HOSPITAL OFFICIALS AND FINAL USERS TO MINIMIZE THE INTERFERENCE OF DRIVING CABLES AND ENERGY FREQUENCY. ECRI RECOMMENDS THAT YOU ALWAYS CONSIDER EMI AS A POTENTIAL SOURCE OF THE MALFUNCTIONING OF EQUIPMENT, ESPECIALLY WHEN THE READING OF THE EQUIPMENT SEEMS TO BE AFFECTED BY NOISE, SORRY OF THE EQUIPMENT BE DULY CONNECTED AND POSTED TO THE PATIENT. IF ANY EMI PROBLEMS ARE SUSPECTED, CHECK THE DOCUMENTATION OF ANY ELECTRONIC HOSPITAL EQUIPMENT THAT IS BEING USED IN THE AREA. WHEN YOU ARE VERIFYING THE DOCUMENTATION, ECRI RECOMMENDS YOU TO VERIFY: (1) IF THE EQUIPMENT IS CLASS A OR B, BECAUSE THE CLASS EQUIPMENT IS EMITTED TO GREATER ELECTROMAGNETIC ENERGY, AND (2) EMI'S SPECIFIC RECOMMENDATIONS FROM THE MANUFACTURER. ECRI RECOMMENDS THAT USERS AND CLINICAL ENGINEER EMPLOYEES SHOULD ALWAYS BE ALTHOUGH YOU HAVE EMI PROBLEMS. IN ADDITION, ECRI RECOMMENDS THAT EMPLOYEES SHALL BE INFORMED OF THE EFFECTS EMI MAY HAVE IN THE OPERATION OF EQUIPMENT AND RECOMMENDATIONS BY ECRI FOR THE REDUCTION OR DISPOSAL OF INTERFERENCE. FOR FURTHER INFORMATION REGARDING ECRI'S EMI RISK REPORT, CONTACT CARLOS FORNAZIER, AT THE ELECTRONIC MAIL TECNOVIGILANCIA@ANVISA.GOV.BR OR BY PHONE 0XX-61-4481331.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Notas adicionales en la data
Acción
The lot. AF91, AEET, AEES, ADVE, ADIS (per 30.06.2001); ACBR, ABUZ, AB57, AAGZ (per 30.04.2001); A9HD, A8SA, A80C, A70K (31.01.2001) of the reagent called UniCAP Total IgE - reference 10-9251-01. AEP8, ADLR (per 30.06.2001); AC7P, AB58, A9JG, A98Y (31.01.2001) of the reagent called UniCAP Total IgE Calibrators - reference 10-9252-01. AE30, ADJH (per 30.06.2001); ACBS, ABFL, AAYG (per 30.04.2001); AARP, AARN, A9HG, A838, A6PK (31.01.2001) of the reagent called UniCAP Total IgE Curve Controls - reference 10-9257-01. AAS3, A73X, A5VB, A5NI (31.01.2001) of the reagent called Pharmacia CAP System IgE FEIA Standards -reference 10-9394-01. AC2L, AAHX (30.06.2001) of the reagent called Pharmacia CAP System IgE RIA Standards - reference 10-9123-0. of PHARMACIA & UPJOHN are withdrawn from the market due to a lack of stability of the calibration solutions and controls used for the determination of total IgE.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Notas adicionales en la data
Acción
Batches 113 and 115 of the reagent called CRP Bireactif - ref. B01744 from BIOTROL DIAGNOSTIC are withdrawn from the market due to an error in the concentration of PEG used for the manufacture of the buffer included in the reagent kit, leading to a risk of erroneous results for patient samples (over- or underestimation obtained from random way).
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Notas adicionales en la data
Acción
Lots 737376901 (per 28.10.00), 739949501 (per 19.01.01), 743293701 (per 30.06.01) of the reagent called CHLORITEST - ref. 62573 of BIOMERIEUX SA are withdrawn from the market due to a lack of stability.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
Test ports of the kits mentioned may indicate false-negative results. the manufacturer started a removal by correspondence, phone and fax on august 23, 2000.
Acción
MAKE SURE THAT YOU HAVE BEEN RECEIVED AND RECEIVED THE MERIDIAN DIAGNOSTICS KNOWLEDGE FORM. IDENTIFY AND ISOLE ANY PRODUCT AFFECTED FROM YOUR INVENTORY. MERIDIAN DIAGNOSTICS AFFIRMS THAT USERS SHOULD DISCONTINUE THE USE OF THESE KITS AND DISCARD THEM. MERIDIAN DIAGNOSTICS ALSO AFFIRMS THAT KIT DISTRIBUTORS SHOULD DISCONTINUE THEIR DISTRIBUTION, NOTIFY REMOVAL CONSUMERS AND PROVIDE A COPY OF THE KNOWLEDGE FORM. FILL IN THE KNOWLEDGE FORM AND FAX FOR MERIDIAN DIAGNOSTICS NO 1 (513) 272-5432. MERIDIAN DIAGNOSTICS WILL REPLACE ANY PRODUCT AFFECTED BY A REPLACEMENT KIT, WITHOUT ADDITIONAL COSTS. FOR FURTHER INFORMATION, PLEASE CONTACT YOUR LOCAL REPRESENTATIVE OR DIRECTLY WITH THE MERIDIAN DIAGNOSTICS TECHNICAL SUPPORT DEPARTMENT BY PHONE 1 (513) 271-3700 IN THE UNITED STATES
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
To date, the existence of 02 registrations of said product in Brazil on behalf of the Companies, UNITED MEDICAL LTDA and MEDTRONIC COMERCIAL LTDA, has been detected. BRASIL - 15.01.2002 - The Company UNITED MEDICAL LTDA, further sells said product, and is finalizing the process of requesting cancellation of registration with ANVISA. BRAZIL - 25.07.2002 - The company MEDTRONIC COMERCIAL LTDA, reports that 46 units were imported, and only 24 units belong to the lot / series that presented problems (30.01.2002). In addition, all replacements and upgrades have been successfully completed.
Causa
Medtronic physio-control received 6 reports of battery failure caused by battery cell rupture. medtronic physio-control stated that each failure involved the rupture of only one battery which led to the opening / rupturing of the packaging box. two of the six reports said that this rupture caused minor injuries to the defibrillator operator, including respiratory irritations and first-degree burns. medtronic physio-control initiated a correction by correspondence dated july 10, 2000.
Acción
Make sure that you have received the July 10, 2000 correspondence and Medtronic Physio-Control replacement batteries. Identify the affected product by removing the battery from the Lifepak 500 automated external defibrillator (AED) to check the part number and date code. If the battery number does not match the numbers of the affected batteries, the battery can be reinstalled. If the battery number matches the affected battery numbers, remove it from use and install a new battery supplied by Medtronic Physio-Control. After installing the new battery, turn the AED on to advise the unit that a new battery has been installed. After 10 seconds, make sure the message "Connected Electrodes" appears. The unit is ready for use. The company estimates that the recall date for this recall is September 30, 2000. For more information, contact your Medtronic Physio-Control representative or technical support at (1-425) 867-4000 in the United States
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
An ecri member hospital reports that when using the model 0606-0300-50 laserscope pulsar / carbon dioxide (co2) lasers for throat surgery, the otolaryngologist complained that the helio / neon laser beam (hene) which indicates the area where the laser will reach the tissue, was not clear enough to be used.
Acción
ECRI makes the following recommendations: (1) Examine the target beam conditions of any Pulsar / Paragon CO2 laser in your hospital during inspection and preventive maintenance to detect any wear of the attenuator over time. Make sure that the aiming beam is immediately visible, especially when used with external light sources. (2) If the beam does not appear to be clear enough, make sure it is set to maximum intensity. If this does not solve, exclude other problems, such as those involving the micro manipulator or wear of the HeNe tube or the power source. (3) If the attenuator is the problem, consider removing the HeNe attenuator assembly (or ask the Laserscope manufacturer to do so). By doing so, you will be avoiding the effort and expense of having to incorporate a Laserscope crosshair upgrade kit, however this will also eliminate the ability to adjust the beam brightness (4) If this does not work , install the Laserscope NeHe upgrade kit. Contact your local representative or directly with Laserscope at 1 (408) 943-0636 in the United States to discuss this option. It may be covered by the original service agreement (warranty) or warranty. Otherwise, Laserscope has stated that the total cost of the service is $ 3,900 (including labor and travel). For more information, contact your local representative or directly with Laserscope at 1 (408) 943-0636 in the United States at fax 1 (408) 428-0512, or visit the Laserscope Web site at http: / /www.laserscope.com.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
The discompression tubes mentioned can be partially obstructed by fungi in the flash, causing the normal tube adapter. distributor started a correspondence removal dated of may 15, 2000.
Acción
MAKE SURE THAT YOU HAVE RECEIVED THE CORRESPONDENCE OF MAY 15, 2000, THE NOTICE OF REMOVAL, THE EFFECTIVENESS FORM AND A BARD INTERVENTIONAL PRODUCTS ENFORCEMENT RESPONSE, PREPAID, SEALED AND WITH THE ADDRESS OF BARD INTERVENTIONAL PRODUCTS PRINTED. IDENTIFY AND COLLECT ANY AFFECTED PRODUCT FROM YOUR INVENTORY. RETURN ALL UNUSED PRODUCTS TO BARD INTERVENTIONAL PRODUCTS BY MAIL AT THE ABOVE ADDRESS, USING THE REMOVAL RETURN AUTHORIZATION NO. 8980 (RECALL RETURN AUTHORIZATION NO 8980). SUBMIT COPIES OF REMOVAL NOTIFICATION FOR THE OPERATORS OF THE BARD, PATIENT AND CONSUMER EQUIPMENT. FILL OUT THE EFFECTIVENESS FORM AND SEND IT TO BARD INTERVENTIONAL PRODUCTS BY MAIL IN THE PRE-PAYMENT ENVELOPE. IF PATIENTS OR EMPLOYEES EXPERIENCE ANY PROBLEMS WITH GASTRIC DECOMPRESSION OR RESIDUAL EXPRESSION, DIRECT THEY TO DO THE FOLLOWING: (1) DRAIN, IRRIGATING AND ASPIRING, THE DECOMPRESSION PIPE. (2) REMOVE THE DECOMPRESSION TUBE AND EVENT WASTE FROM THE TUBE ADAPTER. (3) IRRIGATE THE DECOMPRESSION TUBE AGAIN AND REINSTALL. (4) REPLACE PATIENT TO IMPROVE DECOMPRESSION OR DISPOSAL OF GASTRIC CONTENT. (5) USE ANOTHER TUBE IF PROBLEMS PERSIST. (6) IF ANY TUBE IS REQUIRED OR IF YOU HAVE ANY QUESTIONS, PLEASE CONTACT THE CONSUMER SERVICE OF YOUR BARD INTERVENTIONAL PRODUCTS REPRESENTATIVE.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
An ecri member hospital reported two incidents in which the accession of the bariatric rehabilitation platform is released, causing injury to the nurse. the course of the launder was still under the nurse that has not being adjusting the equipment that holds handling.
Acción
MAKE SURE THAT TEAM MEMBERS ARE TRAINED ABOUT THE CORRECT USE OF THE BED SHEET MECHANISM. REPORT TO EMPLOYEES THAT HANDLING CAN FALL IF IT IS NOT TIGHT WELL. (2) MAKE SURE THAT EMPLOYEES ROTINALLY CHECK THE MECHANISM OF THE LAYOUT OF THE BED TO MAKE SURE THAT THE SAME IS SECURELY ADAPTED / TIGHTENED, AS WELL AS THE OTHER MECHANISMS OF THE BED. (3) ENSURE EMPLOYEES NOT TO DRIVE OR MOVE BRUSHLY AGAINST COURT BURNING TO PREVENT NON-INTENTIONAL LOOSENING. (4) IF THERE ARE ANY SUSPICIOUS PROBLEMS WITH THE BED, PLEASE CONTACT YOUR LOCAL DISTRIBUTOR OR DIRECTLY WITH WHEELCHAIRS OF KANSAS
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
An ecri member hospital reported two incidents in which the accession of the bariatric rehabilitation platform is released, causing injury to the nurse. the course of the launder was still under the nurse that has not being adjusting the equipment that holds handling.
Acción
MAKE SURE THAT TEAM MEMBERS ARE TRAINED ABOUT THE CORRECT USE OF THE BED SHEET MECHANISM. REPORT TO EMPLOYEES THAT HANDLING CAN FALL IF IT IS NOT TIGHT WELL. (2) MAKE SURE THAT EMPLOYEES ROTINALLY CHECK THE MECHANISM OF THE LAYOUT OF THE BED TO MAKE SURE THAT THE SAME IS SECURELY ADAPTED / TIGHTENED, AS WELL AS THE OTHER MECHANISMS OF THE BED. (3) ENSURE EMPLOYEES NOT TO DRIVE OR MOVE BRUSHLY AGAINST COURT BURNING TO PREVENT NON-INTENTIONAL LOOSENING. (4) IF THERE ARE ANY SUSPICIOUS PROBLEMS WITH THE BED, PLEASE CONTACT YOUR LOCAL DISTRIBUTOR OR DIRECTLY WITH WHEELCHAIRS OF KANSAS
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
PRODUCT REGISTERED IN BRAZIL ON 06.05.1999 (INSTRUCOM). HOWEVER, UNTIL THIS DATE, STILL HAS NO MARKETING REGISTRATION. INSTRUCOM COMMUNICATES AS SOON AS THE PRODUCT WILL BE EXECUTED, YOU WILL CLARIFY YOUR CUSTOMERS OF THE FACT THAT HAPPENED, A WAY TO GUARANTEE THE QUALITY OF THE PRODUCT. WHEREVER, THEY HAVE ORIGINAL AND PROFESSIONAL REPLACEMENT PARTS QUALIFIED WITH TRAINING BY PROPRIET MANUFACTURER.
Causa
Hill-rom air-shields edited a product service bulletin disclosing that the company received information that hospitals are replacing the phototherapy system lamps by non-authorized lamps, not compatible by the hill-rom . the phototherapy systems mentioned incorporate lamps with a specific reflector. air-shields hill-rom ends that systems operating without this reflector can generate more heat / energy in the light beam, which could cause equipment failures and commit patient and employee safety.
Acción
MAKE SURE THAT YOU HAVE RECEIVED AIR-SHIELDS HILL-ROM PRODUCT SERVICE BULLETIN. REPLACE LAMPS ON PHOTOTHERAPY SYSTEMS MENTIONED ONLY BY NO. 1780745, WHICH ARE AS SPECIFIED BY HILL-ROM SERVICE MANUALS. INSTRUCTIONS ON THE REMOVAL AND REPLACEMENT OF THE LAMPS MAY ALSO BE FOUND IN SERVICE MANUALS. FOR FURTHER INFORMATION, PLEASE CONTACT YOUR AIR-SHIELDS HILL-ROM REPRESENTATIVE OR PHONE 1 (215) 675-5200 IN THE UNITED STATES.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Notas adicionales en la data
Acción
Lot FP1167 of the reagent called Dimension / Flex Ammonium reagent cartridge (AMON) - reference DF19 - from the company DADE BEHRING SA is withdrawn from the market due to a lack of sealing of some cartridges leading to leakage of reagents and consequently, the possibility of falsely lowered results.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
The reference control of the test kits mentioned does not meet the specifications, which could lead to false-negative results. the manufacturer started a removal by correspondence dated july 21, 2001.
Acción
MAKE SURE THAT YOU HAVE RECEIVED THE CORRESPONDENCE OF JULY 21, 2001 AND THE MERIDIAN DIAGNOSTICS KNOWLEDGE FORM. IDENTIFY AND ISOLE ANY PRODUCT AFFECTED FROM YOUR INVENTORY. MERIDIAN DIAGNOSTICS AFFIRMS THAT CONSUMERS SHOULD DISCONTINUE THE USE OF THESE KITS AND DISCARD THEM. MERIDIAN DIAGNOSTICS ALSO SAYS THAT KIT DISTRIBUTORS MUST DISCONTINUE YOUR DISTRIBUTION, NOTIFY REMOVAL CONSUMERS, AND PROVIDE A COPY OF THE KNOWLEDGE FORM. FILL IN THE KNOWLEDGE FORM AND FAX FOR MERIDIAN DIAGNOSTICS ON PHONE (513) 272-5432. MERIDIAN DIAGNOSTICS WILL REPLACE ANY PRODUCT AFFECTED BY A REPLACEMENT KIT, WITHOUT ADDITIONAL COSTS. FOR FURTHER INFORMATION, PLEASE CONTACT YOUR MERIDIAN DIAGNOSTICS REPRESENTATIVE.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
The reference control of the test kits mentioned does not meet the specifications, which could lead to false-negative results. the manufacturer started a removal by correspondence dated july 21, 2001.
Acción
MAKE SURE THAT YOU HAVE RECEIVED THE CORRESPONDENCE OF JULY 21, 2001 AND THE MERIDIAN DIAGNOSTICS KNOWLEDGE FORM. IDENTIFY AND ISOLE ANY PRODUCT AFFECTED FROM YOUR INVENTORY. MERIDIAN DIAGNOSTICS AFFIRMS THAT CONSUMERS SHOULD DISCONTINUE THE USE OF THESE KITS AND DISCARD THEM. MERIDIAN DIAGNOSTICS ALSO SAYS THAT KIT DISTRIBUTORS MUST DISCONTINUE YOUR DISTRIBUTION, NOTIFY REMOVAL CONSUMERS, AND PROVIDE A COPY OF THE KNOWLEDGE FORM. FILL IN THE KNOWLEDGE FORM AND FAX FOR MERIDIAN DIAGNOSTICS ON PHONE (513) 272-5432. MERIDIAN DIAGNOSTICS WILL REPLACE ANY PRODUCT AFFECTED BY A REPLACEMENT KIT, WITHOUT ADDITIONAL COSTS. FOR FURTHER INFORMATION, PLEASE CONTACT YOUR MERIDIAN DIAGNOSTICS REPRESENTATIVE.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
An ecri member hospital reported that the defibrillation machines mentioned developed fissures and lasks through their borders as they were reterproofed in the time.
Acción
ECRI MAKES THE FOLLOWING RECOMMENDATIONS: (1) NOTIFY EMPLOYEES ABOUT THE PROBLEM, REMEMBER THAT THESE DEFIBRILLATION ACTUATORS HAVE A LIFE OF APPROXIMATELY 200 STERILIZATIONS AND ARE UNDER WARRANTY FOR 1 YEAR. IN ADDITION, ENSURE THAT THE DEFIBRILLATION ACTUATORS MADE BEFORE 1O. OF MARCH OF 1999 MAY BE MORE SUSCEPTIBLE TO FISSURES AND LASKS THAT MOST RECENT MODELS. (2) FOLLOW THE MANUFACTURER'S STERILIZATION GUIDELINES. (3) REPORT TO ANVISA AND THE MANUFACTURER IN CASE OF FISSURES AND LASKS APPEAR WITHIN THE WARRANTY PERIOD OF THE DEFIBRILLATION ACTUATOR SETS MADE AFTER 1O. OF MARCH 1999. (4) REPAIR ANY STERILIZABLE DEFIBRILLATION ACTUATOR SO THAT THEY REPEAT FISSURES OR LASKS AFTER REHOSTERILIZATION. (5) IF THE POSSIBILITY OF A PATIENT IS NECESSARY TO NEED DEFIBRILLATION DURING A PROCEDURE, CONSIDER PLACING DISPOSABLE ADHESIVES IN THE PATIENT BEFORE THE BEGINNING OF THE OPERATION BEFORE USING EXTERNAL DEFIBRILLATION PARTS. THIS WILL REDUCE THE NUMBER OF STERILIZATIONS OF THE DEFIBRILLATION ACTUATORS
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
An ecri member hospital reported that the defibrillation machines mentioned developed fissures and lasks through their borders as they were reterproofed in the time.
Acción
ECRI MAKES THE FOLLOWING RECOMMENDATIONS: (1) NOTIFY EMPLOYEES ABOUT THE PROBLEM, REMEMBER THAT THESE DEFIBRILLATION OPERATORS HAVE LIFE OF APPROXIMATELY 200 STERILIZATIONS AND ARE UNDER WARRANTY FOR 1 YEAR. IN ADDITION, ENSURE THAT THE DEFIBRILLATION ACTUATORS MADE BEFORE 1O. OF MARCH OF 1999 MAY BE MORE SUSCEPTIBLE TO FISSURES AND LASKS THAT MOST RECENT MODELS. (2) FOLLOW THE MANUFACTURER'S STERILIZATION GUIDELINES. (3) REPORT TO ANVISA AND THE MANUFACTURER IN CASE OF FISSURES AND LASKS APPEAR WITHIN THE WARRANTY PERIOD OF THE DEFIBRILLATION ACTUATOR SETS MADE AFTER 1O. OF MARCH 1999. (4) REPAIR ANY STERILIZABLE DEFIBRILLATION ACTUATOR SO THAT THEY REPEAT FISSURES OR LASKS AFTER REHOSTERILIZATION. (5) IF THE POSSIBILITY OF A PATIENT IS NECESSARY TO NEED DEFIBRILLATION DURING A PROCEDURE, CONSIDER PLACING DISPOSABLE ADHESIVES IN THE PATIENT BEFORE THE BEGINNING OF THE OPERATION BEFORE USING EXTERNAL DEFIBRILLATION PARTS. THIS WILL REDUCE THE NUMBER OF STERILIZATIONS OF THE DEFIBRILLATION ACTUATORS.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
An ecri member hospital reported that the defibrillation machines mentioned developed fissures and lasks through their borders as they were reterproofed in the time.
Acción
ECRI MAKES THE FOLLOWING RECOMMENDATIONS: (1) NOTIFY EMPLOYEES ABOUT THE PROBLEM, REMEMBER THAT THESE DEFIBRILLATION ACTUATORS HAVE A LIFE OF APPROXIMATELY 200 STERILIZATIONS AND ARE UNDER WARRANTY FOR 1 YEAR. IN ADDITION, ENSURE THAT THE DEFIBRILLATION ACTUATORS MADE BEFORE 1O. OF MARCH OF 1999 MAY BE MORE SUSCEPTIBLE TO FISSURES AND LASKS THAT MOST RECENT MODELS. (2) FOLLOW THE MANUFACTURER'S STERILIZATION GUIDELINES. (3) REPORT TO ANVISA AND THE MANUFACTURER IN CASE OF FISSURES AND LASKS APPEAR WITHIN THE WARRANTY PERIOD OF THE DEFIBRILLATION ACTUATOR SETS MADE AFTER 1O. OF MARCH 1999. (4) REPAIR ANY STERILIZABLE DEFIBRILLATION ACTUATOR SO THAT THEY REPEAT FISSURES OR LASKS AFTER REHOSTERILIZATION. (5) IF THE POSSIBILITY OF A PATIENT IS NECESSARY TO NEED DEFIBRILLATION DURING A PROCEDURE, CONSIDER PLACING DISPOSABLE ADHESIVES IN THE PATIENT BEFORE THE BEGINNING OF THE OPERATION BEFORE USING EXTERNAL DEFIBRILLATION PARTS. THIS WILL REDUCE THE NUMBER OF STERILIZATIONS OF THE DEFIBRILLATION ACTUATORS.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
An ecri member hospital reported that the defibrillation machines mentioned developed fissures and lasks through their borders as they were reterproofed in the time.
Acción
ECRI MAKES THE FOLLOWING RECOMMENDATIONS: (1) NOTIFY EMPLOYEES ABOUT THE PROBLEM, REMEMBER THAT THESE DEFIBRILLATION OPERATORS HAVE LIFE OF APPROXIMATELY 200 STERILIZATIONS AND ARE UNDER WARRANTY FOR 1 YEAR. IN ADDITION, ENSURE THAT THE DEFIBRILLATION ACTUATORS MADE BEFORE 1O. OF MARCH OF 1999 MAY BE MORE SUSCEPTIBLE TO FISSURES AND LASKS THAT MOST RECENT MODELS. (2) FOLLOW THE MANUFACTURER'S STERILIZATION GUIDELINES. (3) REPORT TO ANVISA AND THE MANUFACTURER IN CASE OF FISSURES AND LASKS APPEAR WITHIN THE WARRANTY PERIOD OF THE DEFIBRILLATION ACTUATOR SETS MADE AFTER 1O. OF MARCH 1999. (4) REPAIR ANY STERILIZABLE DEFIBRILLATION ACTUATOR SO THAT THEY REPEAT FISSURES OR LASKS AFTER REHOSTERILIZATION. (5) IF THE POSSIBILITY OF A PATIENT IS NECESSARY TO NEED DEFIBRILLATION DURING A PROCEDURE, CONSIDER PLACING DISPOSABLE ADHESIVES IN THE PATIENT BEFORE THE BEGINNING OF THE OPERATION BEFORE USING EXTERNAL DEFIBRILLATION PARTS. THIS WILL REDUCE THE NUMBER OF STERILIZATIONS OF THE DEFIBRILLATION ACTUATORS
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
The fda has issued a public health notice informing hospitals that there is a growing risk that digital television and privately owned mobile radio services (plmrs) may interfere with existing medical telemetry systems if it continue to operate in the interval of frequencies where most medical telemetry equipment is operating. the federal communications commission (fcc) created a wireless medical telemetry service (wmts) that would allow the operation of medical telemetry system with a form of protection of interference.
Acción
The FDA DOES THE FOLLOWING RECOMMENDATIONS: (1) DETERMINE IF YOUR WIRELESS MEDICAL TELEMETRY SYSTEM IS RISK OF ELECTROMAGNETIC INTERFERENCE (EMI) BY CONSULTING YOUR MEDICAL TELEMETRY SYSTEM MANUFACTURER. (2) DETERMINE AT WHICH FREQUENCIES YOUR MEDICAL TELEMETRY SYSTEM IS CURRENTLY OPERATING, AND COMPARE THE DATA WITH THE ALLOCATED FREQUENCIES FOR THE DTV AND PLMRS BANDS IN YOUR AREA. (IN THE UNITED STATES, THE LIST OF ALL DTV ACCOUNTS CAN BE FOUND AT THE FCC WEBSITE HTTP://WWW.FCC.GOV/HEALTHNET/DTV.HTML) (3) IF YOU DISCOVER THAT YOUR MEDICAL TELEMETRY SYSTEMS ARE UNDER THE RISK OF IEM BY OTHER RADIO-FREQUENCY (RF) SOURCES THAT OPERATE ON THE SAME BAND, THERE ARE TWO ALTERNATIVES: (A)) REPLACE YOUR MEDICAL TELEMETRY SYSTEMS BY EQUIPMENT OPERATING ON WMTS BANDS (FROM 608 TO 614 MHZ, FROM 1395 TO 1400 MHZ AND FROM 1429 TO 1432 MHZ) WHEN THIS EQUIPMENT IS AVAILABLE, OR (B) MODIFY YOUR EQUIPMENT TO OPERATE ON WMTS BANDS. (4) IF YOU DISCOVER THAT YOUR MEDICAL TELEMETRY SYSTEMS ARE NOT RISEN OF EMI BY OTHER RADIO-FREQUENCY (RF) SOURCES THAT OPERATE ON THE SAME BAND, DO NOT MAKE ANY MODIFICATION. YOU MUST EVALUATE THE RISKS AND MAKE THE NECESSARY MODIFICATIONS AS POSSIBLE, AS LICENSED TV STATIONS ARE AUTHORIZED TO START TESTS AND TRANSMISSION ON DTV CHANNELS.