Events

Safety Alert for DEFIBRILLATOR HEARTSTART XL M4735A - Registration 10216710063 - Serial numbers: as per the annex. http://en.wikipedia.org/w/index.php/

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
    1179
  • Date
    2012-09-13
  • 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 device may shut down unexpectedly without providing the user with a warning message or low battery tone. The XL is capable of running on AC power without a battery. Anvisa is following this field action.
  • Reason
    If the xl defibrillator / monitor (m4735a) is used in a patient when ac power is not in use with a battery code r-2011-12, it may fail.
  • Action
    The record holder recommends: Operate the XL with AC power instead of battery power only. • If you need to operate the XL with battery power only, make sure the battery is of a different Manufacturing Date (it should not have code R-2011-12 for the Date of Manufacture). • If you can not operate with AC power only or find a battery with a date of manufacture other than the one identified above, use an alternative energy source for treatment or therapy (eg, defibrillator / standby monitor). The record holder shall establish action plan for the exchange of battery code R-2011-12.

Device

DEFIBRILLATOR HEARTSTART XL M4735A - Registration 10216710063 - Serial numbers: as per the annex....

Manufacturer

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