Alerta De Seguridad para Hearstart MRx Defibrillator, Philips brand, Model: M3535A, M3536A, Anvisa Registration # 10216710136

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.

If this failure occurs, the MRx may simultaneously display a "No Shock Delivered" message together with a Shock Equip Malfunction INOP and a red X on the RFU indicator. In addition, the ECG waveform of the blades may have a continuous rhythm (non-physiological flat line). The risk was classified as "Results in Serious Damage" and the probability of occurrence was classified as "Expected to occur from time to time. If the problem occurs, there may be a failure of shock application in a patient in need of defibrillation or Philips is initiating a fix on the affected devices.The fix will consist of a software update that will be provided free of charge to all units affected by this problem.A Philips Healthcare representative will contact customers with affected devices for provide the installation of the software update Additional information or support regarding this issue please contact the Solution Center at 0800-701-7789 Customer service from Monday to Saturday from 7:00 a.m. to 7:00 p.m. the link: http://portal.anvisa.gov.br/wps/wcm/connect/891c2e804fa1d403957cf59a71dcc661/Assessment+of+Seguran%C3%A7a+ - + FCO86100121.pdf? MOD = AJPERES