Events

Safety Alert for Heartstart XL M4735A Defibrillator - Registered at ANVISA under the number 10216710063. Serial numbers affected: see http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2009/980_produtos_afetado.pdf.

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
    980
  • Date
    2009-09-16
  • 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 equipment serial numbers that are identified in the Distribution List provided by Philips are affected by this problem. To identify an affected unit, locate the serial number on the bottom of the HeartStart XL. Philips has already initiated corrective action (FSN86100076) of the affected equipment and considers this correction necessary for them. The company is contacting users who have equipment listed in the Distribution List of affected units to schedule replacement of the power selection button. If additional information or support is required regarding this issue, please contact the Philips Medical System Solution Center at 0800-701-7789 (Monday to Friday from 7:30 a.m. to 7:00 p.m. and 8 a.m. to 3 p.m. on Saturdays). When contacting the company, have the corrective action code initiated by the company (FSN86100076) available to facilitate communication. Anvisa's Technovigilance Unit is monitoring this case.
  • Reason
    The power selection knob may fail, preventing the user from turning the equipment on and using it for monitoring and defibrillation. in addition, in some exceptional cases, the error may result in spontaneous connection of the equipment when the equipment is in the "off" position.
  • Action
    Recommended actions for equipment users are as follows: Check your inventory for any product affected by the problem described in this alert. While waiting for the repair time, remove the affected equipment from the use if possible. If it is not possible to remove it from use, look for a backup device that may be readily available in the event that the defibrillator becomes unusable. If you have not been contacted by Philips Healthcare Ltda, please contact the company to request the repair of the equipment in your health care facility.

Device

Heartstart XL M4735A Defibrillator - Registered at ANVISA under the number 10216710063. Serial nu...

Manufacturer

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