Events

Draeger Monitor AC3000 Spring Arm 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
    15702
  • 사례 시작날짜
    2013-11-21
  • 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
    Manufacturer has become aware of a case in which the monitor or support bracket has detached from the joint pin at the bottom of the height adjustable ac3000 spring arm and fallen down together with the monitor until it was only held by the electrical cable connections. no one was injured but a falling monitor support has the potential to cause personal injury if the event was repeated. an inspection of a further seven monitor brackets in the same hospital identified severe wear on the ring groove responsible for the joint pin.
  • 조치
    Product to be modified

Device

Draeger Monitor AC3000 Spring Arm

Manufacturer

Draegerwerk AG & Co KGaA