Events

Recall of LIFEPAK 20E DEFIBRILLATOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PHYSIO-CONTROL CANADA SALES LTD.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    134664
  • Event Risk Class
    II
  • Event Initiated Date
    2017-12-07
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Physio-control is aware that some devices have had power-related failures as customers prepared their device for initial deployment or during use within the first year of distribution. the symptoms of these failures may include unexpected power on and power off device lock-up or a failure to power on or off any of which has the potential to result in a failure to deliver therapy to the patient and serious injury or death. these failures are the result of manufacturing process residue located beneath a component mounted on the power printed circuit board assembly (pcba). there have been no adverse events reported as a result of this issue.

Device

LIFEPAK 20E DEFIBRILLATOR
  • Model / Serial
    Model Catalog: 70507-XXXXXX (Lot serial: > 10 numbers contact mfg.); Model Catalog: 99507-XXXXXX (Lot serial: > 10 numbers contact mfg.)
  • Product Description
    LIFEPAK 20E DEFIBRILLATOR/MONITOR
  • Manufacturer
    PHYSIO-CONTROL CANADA SALES LTD

Manufacturer

PHYSIO-CONTROL CANADA SALES LTD
  • Manufacturer Address
    HAMILTON
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    HC