Events

Recall of OXYLOG 3000 SYSTEM - MAIN UNIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DRAEGERWERK AG & CO. KGAA.

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
    152191
  • Event Risk Class
    II
  • Event Initiated Date
    2015-12-23
  • 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
    Draeger has become aware of situations where the error message "poti unplugged" was generated. in these cases an acoustic and visual alarm is generated the breathing system releases pressure and the ventilation function stops operating. draeger's investigation showed that the error message is caused by increased electrical contact resistance of the controllers (adjustment potentiometers). the increased resistance is the result of an oxide layer on the controllers which accumulates over a long period of time. this oxide layer can only accumulate if the controllers are moved rarely or never. draeger's product monitoring has shown that some users rarely use the controller or do not use it at all.

Device

OXYLOG 3000 SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: 2M86955 (Lot serial: ALL); Model Catalog: 5704811 (Lot serial: ALL); Model Catalog: 5705081 (Lot serial: ALL)
  • Product Description
    OXYLOG 3000
  • Manufacturer
    DRAEGERWERK AG & CO. KGAA

Manufacturer

DRAEGERWERK AG & CO. KGAA