Events

Drager Oxylog Transport Ventilator 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Draegerwerk AG & Co KGaA 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    19613
  • 사례 시작날짜
    2016-01-13
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Recalling Organisation: Draeger New Zealand Ltd, Unit 4, 24 Bishop Dunn Place, East Tamaki, Auckland 2013
  • 원인
    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.
  • 조치
    Manufacturer to issue advice regarding use

Device

Drager Oxylog Transport Ventilator

Manufacturer

Draegerwerk AG & Co KGaA