Events

Recall of Drager Oxylog Transport Ventilator

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand 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
    19613
  • Event Initiated Date
    2016-01-13
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Draeger New Zealand Ltd, Unit 4, 24 Bishop Dunn Place, East Tamaki, Auckland 2013
  • Reason
    In the course of product monitoring, some cases have been reported in which the "poti unplugged" error message was generated. in those cases an audible and visual alarm is generated, the breathing system releases pressure and the ventilation function stops operating., no patient injury has been reported due to this issue., the error message is caused by increased electrical contact resistances of the controllers (setting potentiometers). the increased resistance is caused by an oxide layer formed on the controller over a lengthy period of time. the oxide layer can only form if the controllers are rarely or never moved and according to our product monitoring, some users never, or rarely, use the fio2 controller.
  • Action
    Manufacturer to issue advice regarding use

Device

Drager Oxylog Transport Ventilator

Manufacturer

Draegerwerk AG & Co KGaA