Events

Recall of ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM - MODEL 5000 CONTROL MODULE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BARD CANADA INC..

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
    52235
  • Event Risk Class
    II
  • Event Initiated Date
    2014-08-28
  • 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
    This recall is being initiated by bard canada in order to inform users of a safety concern while using temperature simulator keys with the arctic sun temperature management system. two adverse events have been reported to bard medical division. in each instance a temperature simulator key (product code 748-00 and as part of service kit 771-00) was connected to the patient temperature cable instead of the patient temperature probe. due to the false patient temperature reading from the temperature simulator key improper targeted temperature therapy was delivered to the patients.

Device

ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM - MODEL 5000 CONTROL MODULE
  • Model / Serial
    Model Catalog: 5000-00-00 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 2000-02 (Lot serial: ALL SERIAL NUMBERS)
  • Product Description
    ARCTIC SUN TEMP MANAGEMENT SYSTEM 5000
  • Manufacturer
    BARD CANADA INC.

Manufacturer

BARD CANADA INC.