OXYLOG 3000 SYSTEM - MAIN UNIT 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 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
    152191
  • 사례 위험등급
    II
  • 사례 시작날짜
    2015-12-23
  • 사례 국가
  • 사례 출처
    HC
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 원인
    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

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 2M86955 (Lot serial: ALL); Model Catalog: 5704811 (Lot serial: ALL); Model Catalog: 5705081 (Lot serial: ALL)
  • 제품 설명
    OXYLOG 3000
  • Manufacturer

Manufacturer