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.

Since the second semester of 2011, from its headquarters in São Paulo / SP, from changes in work orders, changes were observed in some modules of DW (Module responsible for pneumatic controls of the Pulmonary Ventilator) above that considered normal. Since it is a highly complex piece, the company decided to alert its partner (manufacturer) in the USA on these technical issues in order to evaluate the performance of these modules, as it is responsible for the Design Controls of the equipment. From this information, the manufacturer has initiated a series of studies and tests in order to find out the causes of the defects presented by the modules. At the beginning of the year 2012, the manufacturer company realized that the defect could be solved from the change of the TCA plate (Module Command Board). Also, according to the manufacturer, the sequence of alarms presented by the equipment when faulty, is as follows: 1) High Peak Pressure; 2) Safety Valve (Release of Safety Valve); 3) Circuit occlusion; 4) Low PEEP; 5) Low Exhalation Volume. These alarms refer to the equipment sending a high peak pressure to the patient in their ventilatory modes. In this way, the equipment activates the mechanism of releasing the safety valves, releasing the pressure, in order to avoid any possible possibility of harm to the patient. There are no notification records in the NOTIVISA system. Anvisa is following this action.

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.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.

According to research by the manufacturer, the root cause is associated with the excessive force required to remove the cable to administer the bolus. This excessive force may result in bolus administration failures, in addition to possible open circuit or Bolus cable short circuit. There are no notifications related to this problem, so far on the NOTIVISA system. Anvisa is following this action. #### UPDATE - 08/14/2012 - The company forwards the Final Report of the Field Action, stating that 100% of the clients were informed of the handling with the handle of the bolus cable of the Infusion Pump - There is no mention of altering the project. #### UPDATE (04/02/2015): HOSPIRA forwarded a new field action report (FA203-01) concerning the replacement of old bolt cables with new cables, the new drawing seeks to avoid premature rupture. Customers will receive the new cables from HOSPIRA and will have to replace them - the old cables must be destroyed by the customers themselves, or sent to the company for destruction. The completion of the replacement is scheduled for March 31, 2015.

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.

Check information presented by the company in the alert message to the user, available at http://portal.anvisa.gov.br/wps/wcm/connect/5dae6d004af1e491820fafa337abae9d/Alerta_1126_Messagem_de_alerta.pdf?MOD=AJPERES

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.

According to the manufacturer, there have been 13 recent cases reported from Linde Healthcare of Sweden related to engine control. Complaints reported were for "non-operation of DC power supply" or "did not power on when operated by internal battery"; "interrupted / damaged contact"; "does not turn on"; "the turbine does not start" and "the machine suddenly shuts off without warning". After investigation, such complaints were associated with failures in the capacitor C53. This may cause the fan to not start or operate on the internal battery. In this cases, it only works with the external battery or AC power cable. #### UPDATE - 08/24/2012 - The company informs that the field action has been extended to replace the motor control board, which contains the capacitor C53 #### SEE ANNEX! http: //portal.anvisa.gov.br/wps/wcm/connect/0ea853804c840cce9c8edd93d95c4045/Carta+ao+Client+Updated+1127.pdf? MOD = AJPERES ## ## Update (05/04/2013): Up to now, the company has corrected 18 units, out of a total of 147 affected equipment.

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.

According to the company, the field action was initiated in view of a complaint from a customer, who noticed that the engine of the equipment was slack, produced unusual noise and stopped suddenly during use. After a root-cause analysis, it was detected that the motor support was broken and that it had small cracks, possibly due to inadequate design of the motor base. The company made improvements in the part and validated the new project, through tests of operation under extreme conditions of use. #### Update (10/26/2012): The company reported having terminated the corrective action on August 23, 2012, correcting 96 equipment (out of a total of 108 units).

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.

For additional information, refer to the Safety Notice issued by Philips (available at http://migre.me/8Weax) or contact the company through the call center - Tel .: 0800 701 7789.

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.

This situation, according to the company, affects only the results of SUSCEPTIBLE TO VANCOMYCIN or INTERMEDIATE SUSCEPTIBILITY TO VANCOMYCIN. All other results of VANCOMYCIN RESISTANT for E. faecium and all MIC / MIC results for organisms other than E. faecium continue to be interpreted correctly. See more in the attached file. http://portal.anvisa.gov.br/wps/wcm/connect/36a690004b2c453eace6afa337abae9d/Alerta_1130_Communicacao_de_Acao_de_Campo.pdf?MOD=AJPERES There are no records related to this problem in the NOTIVISA system. Anvisa follows this field action.

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.

Medtronic has confirmed that an algorithm used in the Model 8870 application card software resulted in nine (9) occurrences of an incorrect date display on the "Schedule to replace the pump by" display. It is estimated that there are more than 140,000 SynchroMed II pump implants worldwide. A patient with a pump that reaches EOS before replacement may feel the return of underlying symptoms and / or withdrawal symptoms of the drug. Patients with intrathecal baclofen may experience baclofen withdrawal, which may lead to life-threatening conditions. No adverse event was reported for eight (8) of the confirmed cases, and one patient on Intrathecal Baclofen Therapy (ITB) experienced a decrease in the therapeutic effect with increased spasticity due to the pump reaching EOS prior to replacement Recommendations: • Continue the follow-up program normal, and monitor the estimated number of months until ERI. This information can be found on the Pump Status screen, the Alarms screen, and the Print Reports Session (see Figure 2). "The" PTM® Model 8835 also indicates whether the pump has reached ERI (Pump Alarm Screen, code 8615). • Follow label recommendations for pump replacement within 90 days * from the ERI statement. To determine the ERI date, review the Pump Status screen and the Alarm screen * A minimum of 90 days at a rate of up to 1.5 mL / day, between ERI activation and EOS, according to the device label .

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.

According to the record holder, the accuracy of the Continuous Infusion system is defined in the product specification contained in the operating manual (+/- 10% +/- 2C). Technical complaints received by the company claim sub-dose and root cause analysis determined variations in infusion characteristics attributed to variation in elasticity property and resistance of the connectors, which can directly affect system performance. Tests performed indicate that the connector exhibits a higher glass transition temperature and is significantly more rigid at room temperature, resulting in a material having an undesirable elastic property and which, when used as part of an infusion mechanism, exhibits significant variation relative to the flow rate accuracy (outside the accuracy limit of +/- 10%). A risk study was conducted by the company to evaluate technical complaints and there are two risk scenarios associated with this situation: Scenario 1: The operator realizes that the patient is not receiving the volume and flow rate programmed during or after the procedure. The completion of this risk assessment has an unacceptable level of safety; Scenario 2: The Biomedical engineer examines the accuracy of the pump before performing the procedure and based on the error presented the procedure is not performed. The completion of this scenario is within acceptable security level. For additional information, consult the alert message issued by the company at http://portal.anvisa.gov.br/wps/wcm/connect/5459c9004b44c2949a6e9aaf8fded4db/Alerta_1133_Apenta_Messagem.pdf?MOD=AJPERES.

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.

DiaSys Diagnostics Systems GmbH, Germany, forwarded the communiqué to Kovalent do Brasil Ltda., Which repacks, labels and markets the One HbA1c FS product in Brazil, stating that one of its customers observed a falsely high HbA1c value of 10, 4%, in a sample analyzed with the DiaSys brand HbA1c IS reagent (photometric analysis). As this value was unlikely, the same sample was evaluated by the HPLC method, giving a value equal to 7.5%. The investigations, to find the cause of the falsely elevated value of HbA1c when tested by photometry, resulted in the diagnosis of Severe Monoclonal Gamopathy of the patient. Gammatids are known to cause nonspecific turbidity in patient samples due to protein precipitation, and therefore interfere with photometric analysis. These are very rare cases and can not be avoided most of the time. There are no reports in the Notivisa system. Anvisa follows this action.

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.

DiaSys Diagnostics Systems GmbH, Germany, forwarded the notice to BioSys Ltd, which markets the One HbA1c FS product in Brazil, stating that one of its customers observed a falsely high HbA1c value of 10.4% in a sample analyzed with the DiaSys brand HbA1c IS reagent (photometric analysis). As this value was unlikely, the same sample was evaluated by the HPLC method, giving a value equal to 7.5%. The investigations, to find the cause of the falsely elevated value of HbA1c when tested by photometry, resulted in the diagnosis of Severe Monoclonal Gamopathy of the patient. Gammatids are known to cause nonspecific turbidity in patient samples due to protein precipitation, and therefore interfere with photometric analysis. These are very rare cases and can not be avoided most of the time. There are no reports in the Notivisa system. Anvisa follows this action.

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.

See the appendices: Requena et alli, 2011 - Adverse reactions to injectable facial fillers. Joint Ordinance SAS / SVS of JAN / 2009. ANVISA Resolution No. 2,732 / 2007. Manifestation CFM / 2006. SBCP / 2006 Manifestation Updated on 05/25/2012.

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.

To date, there are no records in the NOTIFISA system. Anvisa is following this action.

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.

Tests performed by the manufacturer on product samples withheld at the company indicated the loss of heparin potency - some batches failed in the Anti-Factor IIa potency assay. Based on the result of these tests and the fact that these syringes did not meet the requirement of the USP monograph on "power", the manufacturer chose to collect all syringes from the affected lots. In Brazil, the company VR Medical Ltda reported that UTVIG has already initiated the product recall action - according to the company, 135,628 units of the affected product were imported into Brazil, of which 72,793 units have already been sold and 62,835 are in stock. # Update (08/20/2012): The company sent a report of completion of the corrective action to the UTVIG, stating that it had collected / segregated its inventory and destroyed 74,472 product units. Attached to the same document (report of completion of the field action), are the reports of destruction of the products.

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.

Risk assessment presented by Siemens Healthcare Diagnósticos Ltda: Investigations did not demonstrate statistical difference in agreement between the specificity of listed lots and recent batches of the HCV kit. However, differences between the increased rate of observed reactive outcomes vary between laboratories and can be attributed to demographic differences in patient populations. The internal test showed that the estimated specificity agreement for finished batches at 226, 227, 228 and 229 was 99.76% with 95% confidence interval (CI) of 99.43-99.92%. As indicated in the Instructions for Use (UI), the specificity assigned to the ADVIA Centaur HCV assay is 99.90% with 95% confidence interval (CI) of 99.78-99.97%. People whose HCV positive results require more specific additional tests to confirm the presence of virus, viral load and genotype in order to facilitate appropriate therapy. Therapy is not indicated based solely on the immunoreactivity of IgG antibodies to HCV. Therefore, the health risk is absent. As indicated in the Instructions for Use, for samples considered to be reactive to HCV IgG antibodies, it is recommended that the sample be duplicated in duplicate; and if 2 of 3 results are greater than or equal to the Reference Value, the sample is considered reactive and supplemental testing is recommended. Therefore, according to the company, there are no health risks. Positive results should be forwarded for confirmation before being released to patients, whose tests should be repeated in reference methodology. People whose results were positive for HCV require more specific additional tests to confirm the presence of virus, viral load and genotype in order to facilitate appropriate therapy. Therefore, the therapy is not indicated based solely on the immunoreactivity of IgG antibodies to HCV.

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.

During production of a batch of the Sarns High Flow Aortic Cannula, the Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannula connectors. Terumo CVS's preliminary investigation has noted that the substance may be displaced from the surface of the cannula and is likely to be deposited during the molding process - the exact composition of the particle is still undetermined. While Terumo CVS has no other documented examples of this substance appearing during production, the company has determined that all units manufactured in the last three years in the same mold could have been potentially affected. For further information regarding this field action, please visit: http://portal.anvisa.gov.br/wps/wcm/connect/29cca4804b9e0545b6f7b6af8fded4db/Messagem_de_Alerta.pdf?MOD=AJPERES For Company Response Form, go to: http: / / /portal.anvisa.gov.br/wps/wcm/connect/f39d0f804b9e04c7b6d0b6af8fded4db/Formula_de_Resposta.pdf?MOD=AJPERES

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.

When the ceiling monitor suspension falls to its lowest position, there is a possibility of a serious adverse event occurring with the patient or users. The company informed that it will carry out corrective field actions with the affected products in Brazil (FCO72200211). For further information, check http://portal.anvisa.gov.br/wps/wcm/connect/77402d004ba13af7bd1cbfaf8fded4db/Messagem+de+Alerta.pdf?MOD=AJPERES.

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.

Information submitted by Siemens Ltda: Siemens received reports where a drop of the treatment table was observed while the table was moving during operation by manual control. These incidents have been identified due to an internal software timing problem that occurs sporadically. Typically, the desktop software initiates engine control initialization only when the table is stationary. In certain situations the vertical motor control is initialized during table movement. In this particular case, the short time - until the brake has full effect - can lead to a drop down the table for a short distance. On the basis of reports received by the manufacturer from abroad, and after analysis of the problem, the manufacturer carried out the analysis of all the inherent risks and in order to avoid the occurrence of such failure and to improve the inherent safety of the system, a new version of the VD00A software to the patient table. In this way, the Siemens Service representative will perform in the field the modification of the affected systems in order to correct the detected problem. Siemens will perform an upgrade to correct the potential safety problem with the linear accelerator treatment table. A new VD00A version of the treatment table software will be installed. Using the affected systems, if it does present the problem, can cause the table brake to slow down and slide down a little before the brake takes effect and may frighten the patient.

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.

SEE RESOLUTION - RE Nº 3.172, OF JULY 25, 2012, IN ANNEX.

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.

The problem affects the air sensor of the equipment, resulting in a continuous alert and interruption of the procedure. Stopping the procedure during collection of mononuclear cells may result in reworking the procedure. According to the registry holder, the residual risk of air being returned to the patient is low when using the equipment as indicated, even with the existence of the problem mentioned.

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.

The company states that in 2010 its supplier changed the formulation of lubricating oil without informing them. Such changes can cause multiple cracks after 6-12 months, some manifolds have performed well so far. This problem only happened in the manifold manufactured in 2010, since the beginning of 2011 has been changed to another type of lubricating oil. Anvisa is following this action.

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.

Investigations did not demonstrate statistical difference in agreement between the specificity of listed lots and recent batches of HCV kit. However, differences between the increased rate of observed reactive outcomes vary between laboratories and can be attributed to demographic differences in patient populations. The internal test showed that the estimated specificity agreement for finished batches at 226, 227, 228 and 229 was 99.76% with 95% confidence interval (CI) of 99.43-99.92%. As indicated in the Instructions for Use (UI), the specificity assigned to the ADVIA Centaur HCV assay is 99.90% with 95% confidence interval (CI) of 99.78-99.97%. People whose HCV positive results require more specific additional tests to confirm the presence of virus, viral load and genotype in order to facilitate appropriate therapy. Therapy is not indicated based solely on the immunoreactivity of IgG antibodies to HCV. Therefore, the health risk is absent. As indicated in the Instructions for Use, for samples considered to be reactive to HCV IgG antibodies, it is recommended that the sample be duplicated in duplicate; and if 2 of 3 results are greater than or equal to the Reference Value, the sample is considered reactive and supplemental testing is recommended. There are no health risks, according to the Good Laboratory Practices, positive results should be sent to confirmation before being released to patients, whose tests must be repeated in reference methodology. People whose results were positive for HCV require more specific additional tests to confirm the presence of virus, viral load and genotype in order to facilitate appropriate therapy. Therefore, the therapy is not indicated based solely on the immunoreactivity of IgG antibodies to HCV. Anvisa follows this action.

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.

BioMerieux detected that in the Instructions for Use for BACTAT bottles for BACT culture flasks, in Instructions for Use (document number 9300224A), the following steps were omitted: guidelines for the preparation of the MB Bact flask and the requirement to add 1 ml of enrichment to these bottles BioMerieux is providing to those who have received the affected product an Addendum to the Instructions for Use which includes the omitted information. A risk analysis has determined that the problem of "incorrect quantity or no addition of Enrichment Liquid" has a Moderate Risk, with Critical Severity and a Chance of Occurrence as Occasional. The probability was determined to be Occasional because the customer may make a pipetting error or omit the enrichment liquid during the preparation of the bottles. The probability of a lab error has not changed. Customers accustomed to the use of the product usually have protocols that the staff follows which must contain the appropriate volume of the enrichment liquid. Soon new customers would be more sensitive to this problem. However, new customers have the means to find the correct volume in the following locations: 1) in the Quality Control section of the product label, 2) on the bioMerieux website Bact Alert 3D product line - culture media table; 3) through the BioMerieux Customer Service. Based on the number of false negative claims since version 9300224A was released to the field, the absence of the amount of enrichment liquid volume does not appear to have negatively impacted customers and the risk remains Moderate. Consequently the risk in the field has not changed as a result of this problem. Anvisa is following this action.

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.

Abbott confirmed that six batches of the ARCHITECT CA19-9XR reagent show a change in the reported results for patients, and it was found that Abbott controls did not detect this change and presented results within the range. All other batches of reagents are not affected by this change. An internal investigation is under way. Initial indications suggest that the problem is caused by a component of the conjugate. All batches identified below have in common the same component of the conjugate. The investigation and collection of the impacted units in the client are in progress, and the forecast for completion is 09/15/2012. Anvisa follows this action.

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.

When HeartStart MRx Defibrillator Monitors are used in external transport and in SEM environments, the electrical / mechanical connection (pin plugs and / or port pins) between the patient electrode / blade cable (including the CPR therapy cable and the cable of the external electrodes) and the MRx patient connection port may have higher than expected voltage levels, accelerating wear. Without periodic routine inspections and user-initiated preventive actions, wear of the connection may prevent the device from identifying the connection to a patient electrode / blade cable. Such wear may also cause the MRx to inappropriately identify the patient cable from the external or internal paddles and electrodes.