Events

LifePoint bPLUS 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Metsis Medikal Ltd Sti 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
    21574
  • 사례 시작날짜
    2017-06-22
  • 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: Total Safety Solutions Ltd, 19 Bridgehead Cove, Hobsonville, Auckland 0618
  • 원인
    As a result of the momentary communication interruption caused by the software of automatic external defibrillator devices during the self-test procedure, the device got stuck in stand-by during this process and the bios battery was depleted then the device was locked-up due to processor being subjected to low supply voltage during depletion of bios battery and the warning indicator was stuck in green, not switching to red by full depletion of bios battery. the self-test is performed by the main processor and cannot control the indicator position in the event of possible instantaneous communication and lockup problems.
  • 조치
    Software to be upgraded

Device

LifePoint bPLUS
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: Models: LifePoint Pro, LifePoint bPLUS, LifePoint mPLUS
  • Manufacturer
    Metsis Medikal Ltd Sti

Manufacturer

Metsis Medikal Ltd Sti