Events

Recall of BABYTHERM 8000 LDR WARMING BED

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DRAEGER MEDICAL 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
    26564
  • Event Risk Class
    II
  • Event Initiated Date
    2014-08-25
  • 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
    As part of draeger's market and product monitoring they have become aware of a case in which a side panel on a babytherm 8010 did not fully slide to the bottom in the corner guides and was not completely locked. the side panel did not open during this incident and no patient was affected. when reviewing the locking mechanism in a number of hospitals it was possible to fully close the side panels by pushing down on them slightly. however it cannot be guaranteed that the panel will lock into position under its own wieght.

Device

BABYTHERM 8000 LDR WARMING BED
  • Model / Serial
    Model Catalog: FR00050 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: FR 00120 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: FR 00098 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: FR 00114 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    BABYTHERM 8000 LDR WARMING BED
  • Manufacturer
    DRAEGER MEDICAL CANADA INC.

Manufacturer

DRAEGER MEDICAL CANADA INC.