Events

Safety Alert for Heartstart XL Defibrillator, Model M4735A, ANVISA Registration # 10216710063

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by 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
    1364
  • Date
    2014-02-14
  • 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
    The company advises that: As long as your customers are waiting to replace the power adapter of your device, they can continue to use the HeartStart XL. Use a backup defibrillator available to use if the affected HeartStart XL HeartStart XL did not deliver therapy. Access to the alert message: http://portal.anvisa.gov.br/wps/wcm/connect/f7d76c804316062dab25bfe6ad24d25c/Aviso+de+Seguran_FCO86100136.pdf?MOD=AJPERES
  • Reason
    An internal component on the heartstart xl power board may malfunction and potentially affect the ability to deliver therapy. xl may be specifically unable to carry and deliver shock. in addition, when used for external stimulation, malfunction may result in a loss of capture.
  • Action
    parts and pieces field correction

Device

Heartstart XL Defibrillator, Model M4735A, ANVISA Registration # 10216710063

Manufacturer

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