Events

Safety Alert for Heartstart XL Defibrillator - Model: M4735A - ANVISA Registry # 10216710063 - Hazard Class III

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
    1199
  • Date
    2012-09-19
  • 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
    Philips recommends the following measures: • 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). Access security letter to customers and lots involved in: http: //portal.anvisa.gov.br/wps/wcm/connect/a71f70004d731b5a890ae9c116238c3b/Aviso_de_Seguranca_FCO86100117A.pdf? MOD = AJPERES
  • Reason
    If the xl defibrillator / monitor (m4735a) is used in a patient when ac power is not in use, with a battery that may fail, the device may shut down unexpectedly without providing the user with a warning message or low battery tone. there is potential for harm to the patient if the xl shuts off or becomes inoperable when in clinical use to provide therapy (ie defibrillation or non-invasive cardiac pacing) note: the xl is capable of running on ac power without a battery.
  • Action
    corrective action: Safety Notice (FSN) informing affected customers about the possible problem and action to be taken, as well as arranging for the replacement of affected customers' batteries at no charge as soon as new production is available. A Philips Healthcare representative will contact customers with the affected batteries to arrange replacement. Any information or support regarding this issue, please contact us on 0800 701 77 89, Monday to Saturday service from 7am to 7pm.

Device

Heartstart XL Defibrillator - Model: M4735A - ANVISA Registry # 10216710063 - Hazard Class III

Manufacturer

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