Events

Recall of GIRAFFE WARMER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MAQUET-DYNAMED 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
    15309
  • Event Risk Class
    II
  • Event Initiated Date
    2014-04-02
  • 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
    There may be a loss of internal communication that manages the user-adjusted nellcor spo2 alarm settings of the affected giraffe and panda ires warmer systems with nellcor spo2. the alarms may not activate as expected which can result in false positive or false negative saturation and pulse rate alarm notifications to the caregiver. the patient's oxygen saturation and pulse rate values are accurate as displayed however the displayed user-set alarm limits may be different than the actual alarm limits used for alarm activation. all other clinical functionality of the warmer is unaffected.

Device

GIRAFFE WARMER
  • Model / Serial
    Model Catalog: M1231875 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: M1231685 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: M1231863 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: M1118179 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: M1112198 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: 2063570-001 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: 2063568-001 (Lot serial: > 10 NUMBERS CONTACT MFG)
  • Product Description
    GIRAFFE WARMER
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

MAQUET-DYNAMED INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    HC