Optional PS500 External Power Supply Unit Used in connection with Dräger V Series Ventilators 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Draeger Medical Australia Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

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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
    RC-2014-RN-00989-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-09-15
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    Draeger has advised that in some cases in which the battery capacity of the optional ps500 power supply unity of the infinity acs workstation critical care (evita infinity v500) has reduced unexpectedly. the batteries in the ps500 were discharged prematurely, even though adequate battery charge status was displayed on the device. as a consequence of this, draeger published a safety alert in february 2014, as well as a safety recall and the suspension of deliveries for devices using the ps500.
  • 조치
    All PS500 Power Supply Units currently in use are in the process of being upgraded by the Dräger Service Engineers free of charge. A service-charging algorithm will be implemented, which prevents the problem of sulfation of the batteries, which was identified as a main reason for the reduction of the PS500 battery capacity.

Device

  • 모델명 / 제조번호(시리얼번호)
    Optional PS500 External Power Supply Unit Used in connection with Dräger V Series VentilatorsModels: Infinity V500; Babylog VN500; Evita V300ARTG Number: 158739
  • 의료기기 분류등급
  • Manufacturer

Manufacturer