Events

Safety Alert for HEARTSTART defibrillator

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Philips Medical System.

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
    I1412-499
  • Event Number
    2009EBC-0005096
  • Date
    2014-12-04
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=190
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer affirms that the equipment can run weekly automatic tests causing its premature wear and that of its electronic discharge components, besides the possibility that the battery indicator does not reflect the real state of charge, all this obeying an internal configuration of the incorrect software, leading to possible adverse events on the patients are presented.

Device

HEARTSTART defibrillator
  • Model / Serial
    M3535A and M3536A
  • Product Description
    Indicated for cardiac resuscitation and patient monitoring
  • Manufacturer
    Philips Medical System

Manufacturer

Philips Medical System
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    NIDFSINVIMA