Events

Safety Alert for LIFEPAK DEFIBRILLATOR 20. Anvisa Record: 10339190171.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Medtronic Comercial 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
    1023
  • Date
    2010-06-14
  • 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 company received reports of problems associated with the two power supplies of the Lifepak 20 equipment (AC and DC power). AC power failures have been related to specific equipment failures due to network overload, preventing operation with AC power and battery charging. DC power failures have been attributed to waste from the solder flux underneath the component, which causes loss of current in the equipment. For further details, refer to the Field Safety Notice at http://portal.anvisa.gov.br/wps/wcm/connect/3913658042d9e5edba3bbb4817069f5c/Carta+ao+Cliente.pdf?MOD=AJPERES.#### Update ( 24/09/2012): The company informed that it is changing the scope of the field action (reduction of the number of units to be repaired) and that it intends to finalize the field action in Brazil within 6 to 9 months.
  • Reason
    Possibility of failure of the power supply of the equipment.
  • Action
    The following actions are recommended to users of the product: (1) Verify that you have the Lifepak 20 equipment in your inventory; (2) Keep Lifepak 20 defibrillators / monitors operating normally, connected to AC power and keep DC power (continuous current - battery) in continuous charging whenever possible; (3) Follow the recommended daily steps in the Operator's Roadmap (Section 7, Appendix D) to check for possible AC or DC power failures before use; (4) If you identify power failures on some equipment, identify it and segregate it (substitute for another if possible) and contact the product registration holder in Brazil (Medtronic Comercial Ltda.) Or your representatives (Pro Life Medical Equipment and DMAV Medical Support).

Device

LIFEPAK DEFIBRILLATOR 20. Anvisa Record: 10339190171.

Manufacturer

Medtronic Comercial Ltda
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    ANVSANVISA