Events

Laerdal Suction Unit 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Laerdal Medical AS 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
    20417
  • 사례 시작날짜
    2016-08-03
  • 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: Laerdal (New Zealand) Ltd, Unit O, Cain Commerical Centre, 20 Cain Road, Penrose
  • 원인
    There has been a problem identified that is related to use of the laerdal suction unit (lsu) when used with the lsu nimh battery that hase been stored or installed at low temperatures for a prolonged period., the problem may occur if the lsu with a nimh battery, or the nimh battery, has been stored at low temperatures so that the core temperature of the nimh battery is low, typically between 0 °c and 9 °c (32 °f to 48 °f). if used with a nimh battery with low core temperature, the lsu may shut off after some seconds when operated at 350 mmhg or 500+ mmhg (46.6 kpa or 66.5+ kpa) settings.
  • 조치
    Manufacturer to issue advice regarding use

Device

Laerdal Suction Unit
  • 모델명 / 제조번호(시리얼번호)
    Model: 780800 LSU NiMH, Affected:
  • Manufacturer
    Laerdal Medical AS

Manufacturer

Laerdal Medical AS