Events

Draeger Evita 300 with optional PS500 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
    19774
  • 사례 시작날짜
    2016-02-19
  • 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 cases in which the battery capacity of the optional ps500 power supply unit for the evita infinity v500, evita infinity v300 and the babylog vn500 was rapidly and unexpectedly reduced despite using the most recent power supply firmware (fw1 .50) which was released in november 2015. the batteries prematurely discharged, even though an adequate battery charge status was displayed on the device. the "battery discharged" alarm was not in all cases triggered five minutes prior to battery discharge, as specified. when the batteries were completely discharged, the devices triggered the existing power failure alarm correctly. given these new findings, the decision has been made to cancel the distribution of the updated power supply firmware (fw1.50) and to roll back devices on which this firmware version is already installed to fw1.49.
  • 조치
    Product to be exchanged

Device

Draeger Evita 300 with optional PS500
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: Optional PS500 Installed
  • Manufacturer
    Draegerwerk AG & Co KGaA

Manufacturer

Draegerwerk AG & Co KGaA