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
Some defective pumps have been included in the mentioned talas assemblies or sent as replacement pumps for replacement. the factory initiated a removal by letter dated august 23 and august 24, 2000.
Acción
Make sure you have received the letter dated August 23 or 24, 2000 from Cramer Products. Identify and isolate any defective product from your inventory. For more information, contact your local representative or directly with Cramer Products. Clarification: The factory stated that 341 damaged pumps were returned
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 primary blister packaging of the mentioned units may have cracks that may compromise the sterility of the product. the manufacturer initiated a telephone recall on june 28, 2000 and by mail dated august 25, 2000.
Acción
Make sure that you have received the Medical Equipment Removal Notification correspondence dated August 25, 2000 and the Stryker Endoscopy Knowledge Receipt. Identify and isolate any affected product from your inventory. Return any affected product with return authorization, at no additional cost, to Stryker Endoscopy by mail at the above address. Contact your local representative or directly with the Stryker Endoscopy Customer Service Center by phone to receive a return authorization. Stryker Endoscopy states that upon receipt of the Receipt of Knowledge, it will automatically begin shipping the replacement product. Sign and complete the Knowledge Receipt and send it to Stryker Endoscopy by mail at the above address or by fax at 1 (408) 567-2505. For more information, contact your local representative or directly with Judy Toste, Stryker Endoscopy, by mail at the above address or fax 1 (408) 567-2505
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 in examining a problem with the bed frame structures mentioned, maintenance staff discovered a crack in the corner joint weld (ie, an area where two or more pieces of metal are welded). the hospital claims that the units were in use for about six months only. the nurses were not aware of the problem, and as a result, the hospital can not determine when the cracks occurred. the hospital says that the manufacturer hard changed the bed structures and that no other unit presented the problem.
Acción
ECRI makes the following recommendations: (1) Periodically inspect all welds in cribs for wear or cracks. The HARD manufacturer recommends annual inspections, but ECRI believes that semiannual inspections are more appropriate. The manufacturer HARD says it will inspect the beds produced by them in their hospital for free. (2) Remove any cracks where any cracks appear and contact your local dealer or directly with the HARD manufacturer for replacement of the frame. ECRI states that preventive maintenance procedures are available in a free manual provided by the manufacturer HARD; the manual also includes prior risks and crib alerts, as well as the current FDA product regulations. Contact your local dealer or directly with the HARD manufacturer by mail for the manual or to inquire about inspection services.
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 uk has demanded of impra to provide better instructions for use of the aforementioned prostheses to alert doctors in removing the small bubble and also demanded of impra withdrawing the product from the market to remedy the problem. the manufacturer initiated the recall of the defective product outside the united states by mail dated may 1999 and august 2000.
Acción
Make sure that you have received the dated May 1999 and August 2000 correspondence from Impra. Identify and isolate any affected product from your inventory. ECRI recommends that you inform if any of the above units have been deployed in your institution and by whom. Tell the implant surgeon that the product is subject to removal. It is up to the cardiac surgeon to decide on the need for medical intervention in patients who have been implanted with the product. No action is necessary in the United States. For removal instructions, contact your local representative or directly with Impra at (1) (480) 894-9515 in the United States. ANVISA recommends that your establishment ensure that all patients who have these products in place are followed periodically and that this follow-up is documented in order to protect their implantable physicians and their establishment from a legal point of view. If it is necessary to replace the implants, if there is any difficulty in recovering from the manufacturer, immediately contact the ANVISA Technovigilance for arrangements.
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
Incorrect results can be obtained if the wash stand is placed on the above analyzers before placing the analyzer in stand by or stop mode. the manufacturer initiated the correction by means of a product correction letter (consumer bulletin) dated august 1, 2001.
Acción
Verify receipt of the product correction letter (consumer bulletin) dated August 1, 2001 from Roche Diagnostics. Identify any affected product in the inventory and follow the instructions on the product repair letter. For more information, contact your local representative or directly with Roche Diagnostics at (317) 845-2000.
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 above sets may leak fluid or air when the long obturator is inserted into the hemostasis valves. assemblies distributed after may 31, 2001 have a shorter shutter and are risk free. the manufacturer initiated the removal by means of a letter dated july 23, 2001.
Acción
Check receipt of the letter dated July 23, 2001 from the manufacturer Arrow International. Identify and isolate any affected product in inventory. Return any affected product to the above address to the care of Scott Carlisle, Quality Control Manager, Arrow International. The freight of the products will be free. The product exchange will be automatically posted at no cost upon presentation of return receipts. For further clarification or adjustments, please contact your local representative or telephone (610) 378-0131 (calls from outside 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
The scalp boxes listed above have sealing defects which may compromise the sterilization of the products. the manufacturer initiated the removal by means of a letter dated june 26, 2001.
Acción
Check receipt of the letter dated June 26, 2001 from ZNC. Identify and isolate all inventory products. Do not use the affected products. ZNC recommends that you contact the supplier to exchange the affected product for replacement. For more information, contact your local representative or ZNC at
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 power supply to the monitors listed above may fail when the printer / recorder is activated, thus causing a temporary loss in the alarm activations. datascope states that for most patients, the risk associated with power failure may be insignificant; however, the risk is increased in patients with unstable medical conditions. if a monitor restarts in the absence of a medical staff, the patient may be left unmonitored for up to 35 seconds and all temporary alarm activations will be changed to the last saved settings without any indication to the clinician. the manufacturer initiated the correction by letter dated may 25, 2001.
Acción
Verify receipt of the correction notice dated May 25, 2001 from Datascope. ECRI recommends that you identify and isolate the entire affected product in the inventory. A Datascope representative will replace the current power supply at no charge. At the end of the job, you will be asked to sign a service report to check the degree of job satisfaction. Meanwhile, ECRI suggests that the record alarm function be set to "off" to prevent automatic printing if the alarm sounds. Let the impression be manually activated by a clinician in the patient's presence so that the patient is observed if the monitor restarts. For more information, contact your local representative or the telephone number (201) 995-8237 (outside 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
The power supply to the monitors listed above may fail when the printer / recorder is activated, thus causing a temporary loss in the alarm activations. datascope states that for most patients, the risk associated with power failure may be insignificant; however, the risk is increased in patients with unstable medical conditions. if a monitor restarts in the absence of a medical staff, the patient may be left unmonitored for up to 35 seconds and all temporary alarm activations will be changed to the last saved settings without any indication to the clinician. the manufacturer initiated the correction by letter dated may 25, 2001.
Acción
Verify receipt of the correction notice dated May 25, 2001 from Datascope. ECRI recommends that you identify and isolate the entire affected product in the inventory. A Datascope representative will replace the current power supply at no charge. At the end of the job, you will be asked to sign a service report to check the degree of job satisfaction. Meanwhile, ECRI suggests that the record alarm function be set to "off" to prevent automatic printing if the alarm sounds. Let the impression be manually activated by a clinician in the patient's presence so that the patient is observed if the monitor restarts. For more information, contact your local representative or the telephone number (201) 995-8237 (outside 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
In the older versions of the software for the radiotherapy systems, there was acceptance of inappropriately inserted blocks in a different way than was specified in the user manual. when a block is inserted improperly, the software can calculate an unexpected overdose of radiation that may go unnoticed by the user and cause harm to the patient. the manufacturer initiated a voluntary correction work through a letter dated 12.09.01 and sent all customers a software maintenance and maintenance package with a support system entitled project safeguard, which consists of a modified version of the block scanning program.
Acción
Make sure you have received the letter and the package with Project Safeguar. Install the updated Maintenance Pack as instructed on the diskette label. This should take about 35 seconds. A filter that rejects an unacceptable block is included in the modified version of the block scan program. This maintenance update is only a specific upgrade to the block scanning program and will not affect the performance or any other function or configuration of the treatment planning system. For more information, and to notify Multidata's helpdesk after receiving the update package, contact Multidata via telephone in the USA at 1 (314) 968-1001 or 1 (314) 968-6443, or by email: helpdesk@multidata-systems.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
In the older versions of the software for the radiotherapy systems, there was acceptance of inappropriately inserted blocks in a different way than was specified in the user manual. when a block is inserted improperly, the software can calculate an unexpected overdose of radiation that may go unnoticed by the user and cause harm to the patient. the manufacturer initiated a voluntary correction work through a letter dated 12.09.01 and sent all customers a software maintenance and maintenance package with a support system entitled project safeguard, which consists of a modified version of the block scanning program.
Acción
Make sure you have received the letter and the package with Project Safeguar. Install the updated Maintenance Pack as instructed on the diskette label. This should take about 35 seconds. A filter that rejects an unacceptable block is included in the modified version of the block scan program. This maintenance update is only a specific upgrade to the block scanning program and will not affect the performance or any other function or configuration of the treatment planning system. For more information, and to notify Multidata's helpdesk after receiving the update package, contact Multidata via telephone in the USA at 1 (314) 968-1001 or 1 (314) 968-6443, or by email: helpdesk@multidata-systems.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
One hospital, a member of the ecri accident reporting system, reported loosening and peeling of the screw threads above all of these surgical foci in their inventory. the manufacturer states that these problems would not occur if the threads remain on these special screws. the hospital also reported paint chips in the balance of all these surgical foci, which probably resulted from contact with intravenous fluid bottle holders, shelves with monitors or other equipment. both problems could result in aggravations or contamination of sterile fields. hill-rom is currently contacting customers to see if other outbreaks are affected by the same issues.
Acción
Check in your inventory if you have any other surgical focus. Determine if the bolts are loose and / or if the paint is peeled. At the moment, Hill-Rom is working on a solution to fix both problems. For more information, or to inform the manufacturer of problems with outbreaks in your inventory, contact your local Hill-Rom representative or directly at 1 (812) 934-8189 in the USA. ANVISA has provided the Occurrence Notification Forms on the Internet www.anvisa.gov.br/tecnovigilancia to notify you if you encounter any problems with the products in your inventory. ECRI suggests using a locking wire and / or adhesive to hold the thread in place until Hill-Rom solves this problem. To minimize the risk of ink chipping, ECRI recommends that hospital staff be advised to avoid impact of the equipment with other metal brackets. Touch up or protect with adhesive any area containing peeling paint. If some threads are loose or missing in the foci of your inventory, or need paint for touch-ups, call the manufacturer to receive them. In addition, ECRI suggests positioning the focus elsewhere to reduce the chance of injury or contamination. Additional comment: One week after the publication of this Alert, Ecr i had a telephone conference with Hill-Rom, the company acknowledged this week's suggestions and announcements and requested that any affected customer contact Hill-Rom at mentioned above for information and
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 top of the laser pointer laser aimers can detach itself from the image intensifier.
Acción
Identify and isolate any affected product in your inventory. GE OEC will modify the device by April 21, 2002. For more information, contact your local GE OEC representative by phone or fax at 1 (801)536-4646 directly in the USA.
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 error in the software may cause incorrect jaw positioning of the system. the manufacturer initiated a telephone call (correction) on september 17 and 18, 2001. the firm did not provide any information to ecri.
Acción
Make sure you received a call from Radionics on September 17 or 18, 2001. Identify and isolate any affected product in your inventory. For more information, contact your local Radionics representative or 1 (781) 272-1233 in the USA.
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
Under excessive shock per load, the pin of the latch foot lock remains in the unlocked position and can bend, bend, bend. when bending, it can cause a locking in the pin that is collected instead of normally extended, which will cause the legs of the stretcher to remain unlocked at all times. using a stretcher without a catch on your feet is dangerous because it may fall suddenly. an unexpected drop can cause discomfort to the patient being transported or its operators. the manufacturer initiated a correction by an urgent correction news dated september 14, 2001.
Acción
Verify that you have received Urgent Correction News dated September 14, 2001 with replacement parts, containing the pins, installation instructions, order forms from other kits, and the prepaid envelope for the post to Ferno Washington. Identify and isolate any affected product from your inventory. Check the feet of each of the stretchers by testing the retractibility of the pins as follows: (1) Place the stretcher in the highest position. Remove the mat and / or lift the adjustment frame. Locate the span of the pins in the channel "C" on each side of the feet. (2) Note that the brass pins extend to lock the frame. When extended, the pins protrude out of the channel. Shaking to free the feet and change the position, causes the retraction of the pins and allows to move the structure. When the controls are released, the pins jump into the understood position, ready to engage when the frame rests back. (3) Make sure the pins are operating properly by releasing the controls several times and observing the movement of the pins. Both pins at the foot of the stretcher should extend and retract when the controls are shaken and released. If both pins retract after release of the control and the legs of the stretcher do not lock, this stretcher must be removed from service until the local Ferno Washington Service Representative can complete the replacement parts. Each set has number of series that correspond to the series numbers of the original products. If you choose to install the replacement part yourself, Ferno offers you, in return for your working time, a SAVER medical emergency kit, when you return the original part and the return set with the completed letter to the specified address. For more information or to have the installation service, contact your local Ferno Washington representative or directly at 1 (937)382-1451 in the USA.
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
Notas adicionales en la data
Acción
Brainlab AG safety note regarding the product BrainSCAN versions 5.31 and 5.32.
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 received an account of a member of the system on the electric scalpel blade, which broke during two cardiac surgeries, using the above mentioned apparatus. the blades were left inside the chest cavity and were not recovered. even with malfunction of the device, no injury occurred in the patient. the manufacturer, who is aware of this problem, has done an investigation to determine the cause. he found a situation similar to that described, surgeons are often using an instrument to shave or clean another, causing displacement in the instrument of the unit.
Acción
The manufacturer asks to advise surgeons that they should not use an instrument to clean another when the Da Vinci Robot is being used (running). He also provided further instructions and training for surgeons who use the system for the purpose of alerting and underlining this case. Intuitive Surgical has created a new insertion tool, which makes it difficult to drop the blade out of the instrument. The manufacturer claims that this modification has reduced the number of adverse events. For more information or if you have not received the new instructions, training and / or insertion tool, please contact Surgical at 1 (650) 237-7000.
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 above mentioned fan circuit may have a manufacturing defect (series / batch). in some cases, the cable connector used to secure / hold the guidewire close to the patient, on the y connection, may not have been mounted correctly. this may result in a malfunction in the wire / cable heater. the manufacturer commenced a voluntary correction work through the urgent correction process with a letter dated october 12, 2001.
Acción
Make sure you have received the letter and the white posting card for Hudson RCI return. Identify, isolate, and immediately discontinue use of the affected product in your inventory. The manufacturer recommends follow-up to reduce the possibility of sparking, overheating and / or ignition with the circuit. The following measures are recommended: (1) The wire / cable circuit should never be stretched or with high condensation / secretion. (2) Do not use the breathing circuit for more than 5 days. Complete all required information on the prepaid white return card if you have or have any affected product in your inventory, and return the prepaid return card to Hudson RCI by mail to the address or fax at 1 (909) 676 -1578. For more information on how to return the affected product, obtain the authorization number, or more information, contact your local Hudson RCI representative or directly at 1 (909) 676-5611 in the USA.
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 unit mentioned above may not be sterile. the manufacturer initiated a correction work by letter dated september 12, 2001. the firm did not give any information to ecri.
Acción
Make sure you received the letter dated September 12, 2001 at. 164 of Johnson & Johnson. Identify and isolate any affected product in your inventory. . For more information, contact your local Johnson & Johnson 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 anomaly, which fails to detect low heart rates at a frequency of 12 to 15 beats per minute, may exist in the electrocardiographic monitoring module above. for this anomaly to occur, three things have to occur simultaneously: (1) the heart rate has to fall suddenly within a beat interval. (2) the rhythm of the heart has to fall within the oscillation of 12 to 15 beats per minute. (3) the heart's rhythm must remain within the oscillation of 12 to 15 beats per minute. in this condition, the software will not update, detect the change or may generate a low-beat alarm. there were no injuries or deaths in patients associated with this anomaly and any heart rate outside of this range will provide an appropriate alarm. the manufacturer initiated a field correction through a letter dated october 22, 2001, called the emergency medical device corrective action.
Acción
Make sure you have received Spacelabs' October 22, 2001 letter Identify and isolate any affected product in your inventory. Spacelabs is offering replacement software to correct the anomaly associated with the above modules. If you have the drives with models No. 90342, 90344, 90346, 90348, 90470, or 90478 in your inventory, the manufacturer is offering the opportunity to do an upgrade on its own. If you choose this action, you must sign up to be included in the program. The manufacturer will then provide, free of charge, the upgrade software for each affected unit and instructions on how to make the upgrades. After you complete and sign an installation modification report for each affected module and return the affected software for each module, you will receive $ 25 of credit in your account for each updated model, valid for maintenance or purchase of products within 12 months. For customers who choose not to participate in this opportunity or if you have the model no. 90496 upgrade software will be installed by the on-site representative of Spacelabs at no charge. The manufacturer estimates that each update will take about 30 minutes. Until your ECG modules are up-to-date the manufacturer recommends that you be aware of the above-mentioned anomaly to prevent any adverse events from happening. For more information, contact your local representative or directly with Spacelabs Technical Monitoring Support by phone 1 (206) 882-3700 in the USA.
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 a case in which the patient had a skin lesion caused by a disposable oximetry sensor. a large section of the insulation that is normally placed on the led, light emitting diode, part of the sensor, has been ripped or plucked off, causing contact of the sensor electrical connection with the patient's skin. investigations of ecri regarding this incident revealed that the burn was more electrochemical than thermal, and was caused by a low voltage (voltage), direct electrolyte current in the tissue, which occurred in the exposed location with the electrical connection.
Acción
Electrochemical burns from the Pulse Oximetry Sensor can be prevented by not exposing the damaged electrical connection of the sensor to contact with the patient's skin. ECRI recommends the following to prevent the occurrence of such burns: (1) Alert the hospital staff of this problem and our alerts. (2) Ensure that the clinical protocol includes a check of the integrity of all pulse oximetry sensors (both disposable and reusable) before they are placed in the patient and when they are removed to a new location. Especially, inspect the sensor and sensor cable for cracks and cracks in insulation, electrical connection or wiring, and for any other damage. Only reuse the disposable sensor in the same patient according to the directions of use of the sensor supplier. (3) Instruct the staff to follow the provider's instructions when checking the integrity of the skin lying under the sensor and when changing the sensor location. By doing this, it will certainly help, prevent any injury, or if it occurs, to be treated immediately. (4) Inform personnel not to use damaged sensors or cables. The damaged sensor or cable must be clearly labeled "damaged" and sent to clinical engineering for evaluation and tracking of occurrences associated with health products. Notify ANVISA through the Notification Form associated with Health Products, available on the Internet www.anvisa.gov.br/tecnovigilância or by e-mail tecnovigilancia@anvisa.gov.br, or by fax 0xx61-4481257
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 above mentioned vessels, for transplantation, were collected from a donor that was not properly evaluated. the manufacturer initiated a correction by letter dated 1st. november 2001. the firm did not give any information to ecri.
Acción
Make sure you received the letter dated November 1, 2001 from CryoLife. Identify and isolate any affected product in your inventory. For more information, contact CryoLife by phone at (800)438-8285.
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 above mentioned parts were sterilized and labeled "sterile" during the beginning of the manufacturing process. however, during the rework process, it is possible that some of the batches identified above have not been resterilized. the manufacturer initiated a letter correction dated july 13, 2001, to warn customers that some products from suspect lots may have been transported without resterilization. to date, 804 of the 3,595 articles have already been returned to the manufacturer.
Acción
Make sure you have received the Nobel Biocare letter of July 13, 2001. Identify and isolate any affected product in your inventory. For more information, contact your local Nobel Biocare representative or directly at 1 (714) 282-4800 ext. 5073 in the USA.
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
The central monitoring stations above may have locks on the cpu. during cpu blocking, the following occurs: (1) the acuity software screen freezes and no interaction with it is possible. (2) a small white console window appears on the screen. (3) an error message appears in the window indicating that a crash occurred on the cpu. (4) a prompt indicating ¿ok¿ appears, instructing the user to use the ¿go¿ key; however, acuity software does not allow the user to use this required action. the manufacturer initiated the correction by means of a letter dated june 1, 2001.
Acción
Verify that you received the correction letter and the response card dated June 1, 2001, submitted by Welch Allyn. The company recommends the following: (1) Disconnect the affected CPU from the main power switch located behind the CPU near the power cord input. Wait for at least 10 seconds before turning it on again. The Acuity software will restart automatically. (2) If the Acuity software system is equipped with a high availability system, follow the internal procedure of your equipment to power it back up for backup. This usually involves switching the A / B switch from the video to position B and using the respective backup of the CPU and trackball. This will allow high CPU availability to have primary control of all monitoring functions. (3) If the high availability system is subject to a CPU crash, follow the same guidelines as described above by manually turning the key on after 10 seconds of waiting. (4) Report the above CPU failure to your local representative or directly to the Welch Allyn Technical Services Department at 1 (503) 526-8500 (in the United States). All affected Sun Microsystems workstations will be upgraded at no charge. Fill out the response card and return it to the Welch Allyn address. A Welch Allyn representative will contact you to help you resolve this problem. For more information, contact your local representative or directly with the Welch Allyn Technical Services Department from 8:00 AM to 5:30 PM (local time in the United States, please remember that it is 3 hours less than Brazil) by phone 1 (503) 526-8500.