Events

Safety Alert for Product name: Defibrillator Hearstart MRx, Philips brand Technical Name: Defibrillator ANVISA Registration Number: 10216710136 Hazard Class: III Affected Model: M3535A, M3536A

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Philips Medical Systems Ltda.; Philips Medical Systems..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    2210
  • Date
    2017-03-07
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    Issue 1: When inspecting the device, check the battery compartment connections of the HeartStart MRx. Include this step as part of a routine Operational Check to confirm that the battery connector pins are clean, fully extended, free of kinks and no debris. Problem 2: After the device is disconnected from the AC power, if the External Power Indicator light above the MRx screen remains on, the device did not switch properly to battery power and is at risk of exhibiting abnormal behavior recharge and stimulation. When disconnecting the MRx from the AC mains, observe the External Power Indicator. If it remains lit, take the following actions to restart the drive: Leave the device disconnected, Remove and reinsert the battery, and Confirm that the Indicator has cleared. There are two ways to prevent this alternation of energy. You can: Remove the AC module from the MRx instead of disconnecting the AC power cord. The. Turn on the MRx using the knob and allow it to complete initialization before disconnecting the device from the AC power. B. Philips also reminds you to keep the batteries fully charged before use according to the HeartStart MRx Monitor / Defibrillator Instructions for Use (IFUs).
  • Reason
    Problem 1: if the battery connection pins (in the heartstart mrx monitor / defibrillator battery compartment) are damaged or contaminated, this could result in a poor electrical connection that may cause the mrx (i) ) restart repeatedly, when used only with battery power. problem 2: after disconnecting the device from the ac power outlet, you may notice two abnormal behaviors of the heartstart mrx monitor / defibrillator: 1. after the user presses the charge button, the device attempts to recharge, and after approximately 20 seconds, generates the error message "shock equipment malfunction" and can not apply shock therapy. 2. the stimulus may be interrupted without warning. these device behaviors continue until the drive is restarted (as described in the section "action taken by the client / user"). these abnormal device behaviors are very uncommon and difficult to reproduce consistently. two different events must coincide for the behavior to occur: 1. when the user turns off ac power, the mrx remains incorrectly in the operating mode of the "ca mains" and fails to switch to "battery only" [battery only]. 2. the battery is at least partially consumed. these behaviors do not occur when the device is operating on both batteries. there are no reports of these behaviors when the device is disconnected from dc power.
  • Action
    Field Action Code FCO86100179 released under the responsibility of Philips Medical Systems Ltda. Company will send addendum to the Instructions for Use.

Device

Product name: Defibrillator Hearstart MRx, Philips brand Technical Name: Defibrillator ANVISA Reg...

Manufacturer

Philips Medical Systems Ltda.; Philips Medical Systems.
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    ANVSANVISA