Events

Safety Alert for HeartStart MRx Defibrillator - Models M3535A, M3536A - Registration 10216710136 - Serial Numbers - See Annex (http://migre.me/9GSbs).

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

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
    1148
  • Date
    2012-06-29
  • 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
    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.
  • Reason
    The patient cable of the electrodes / paddles and the patient connection port may pose risks to patients and / or health care professionals.
  • Action
    Carefully read the Appendix - HeartStart MRx Instructions for Use. Immediately perform continuous inspection of the connections of all your MRx devices to detect wear at higher than expected voltage levels. The Annex - HeartStart MRx Instructions for Use describes how a wearer can identify wear. If wear is detected, immediately remove the affected devices and contact Philips to arrange maintenance. NOTICE: The life of your patient / external electrode cables is up to three years. To maintain reliable performance and reduce the possibility of failure during patient use, replace such parts every three years from the time they were put into service or if they do not meet the criteria set out in the Annex - use. (http://migre.me/9GSkE)

Device

HeartStart MRx Defibrillator - Models M3535A, M3536A - Registration 10216710136 - Serial Numbers ...

Manufacturer

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