Events

Safety Alert for HEARTSTART MRX DEFIBRILLATOR - Models M3535A and M3536A. Anvisa Registry: 10216710136.

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
    1022
  • Date
    2010-06-02
  • 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
    According to information presented by Philips Medical Systems Ltd., after two years of continuous use mechanical wear caused by vibration and frequent disconnections may cause an intermittent electrical connection between the battery and the equipment. The power outage during the use of the equipment may cause it to restart with interruption of therapy (monitoring of the electrocardiogram / electric shock for defibrillation of the heart muscle). #### Update (20/06/2012): Philips Medical Systems Ltda informed the UTVIG about the completion of the field action. According to the company, the addendums to the instructions for use were sent to affected customers in Brazil.
  • Reason
    Blinking electrical connection between the battery and the equipment, which may cause the defibrillator to fail.
  • Action
    The company sent an informative letter to customers, with an addendum to the instructions for use of the equipment (Notice of Application of the Instructions for Use of the Lithium Ion Battery M3538A). It is recommended that all affected batteries be replaced after two years of continuous service, or when the battery capacity calibration fails, whichever comes first. The details of the instructions should be verified in the Letter to Customers (available at http://portal.anvisa.gov.br/wps/wcm/connect/f13aa60042b4e27f8b89cbb134f70e0f/Carta+a++Clients.pdf?MOD=AJPERES) and in the Addendum to Instruction Manual (available at http://portal.anvisa.gov.br/wps/wcm/connect/3b74638042b4e3228b92cbb134f70e0f/Adding+to+Manual+of+Instructions+.pdf?MOD=AJPERES) .

Device

HEARTSTART MRX DEFIBRILLATOR - Models M3535A and M3536A. Anvisa Registry: 10216710136.

Manufacturer

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