Events

Safety Alert for LIFEPAK CR PLUS AUTOMATIC EXTERNAL DEFIBRILLER, Model LIFEPAK CR PLUS, Registration no. 10339190167, Serial no. - see attached list

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
    1237
  • Date
    2013-03-18
  • 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
    Please note that your defibrillators may be affected by this anomaly and that they should be checked regularly for proper functioning (appliances and batteries) as indicated in the Operating Instructions for as long as they are in their possession. For any questions or concerns, contact the Company's Technical Assistance by e-mail or by calling 11-2187-9212, Monday through Friday, at the following times: 08:30 to 17:30.
  • Reason
    Lifepak cr plus external automatic defibrillators are battery-powered devices and require the batteries to operate and deliver the desired therapy. the charge-pak ™ replaceable battery charger is designed to be replaced approximately every 2 (two) years. in some circumstances, the life of the charge-pak replaceable battery charger has not reached the period of 2 (two) years due to an internal electrical fault that leads to the early exhaustion of the internal battery of the defibrillators. the defibrillator display continues to communicate the status of the device and the battery correctly even if the device is affected by this anomaly.
  • Action
    The company directs to verify if the serial number of the defibrillator in use in the service is in the relation of the numbers of affected series and requests to follow the instructions contained in the letter to the client: URGENT SAFETY NOTICE - LIFEPAK CR® Plus FSCA - FA260 External Automatic Defibrillators attached to this alert). If the problem is identified, the company's technical assistance should be contacted for collection of the equipment and after returning the defibrillator to Physio-Control for verification, the device will be analyzed to determine if it is affected by the anomaly of early exhaustion the internal battery. If the defibrillator is affected, the company will provide a permanent replacement device.

Device

LIFEPAK CR PLUS AUTOMATIC EXTERNAL DEFIBRILLER, Model LIFEPAK CR PLUS, Registration no. 103391901...

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