Events

LIFEPAK 15 Monitor/Defibrilators with End-Tidal CO2 (EtCO2) functionality 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Physio-Control Australia Pty Ltd 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
    RC-2017-RN-00296-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-03-02
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00296-1
  • 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
    An issue has been identified where the etco2 reading on the lifepak 15 can intermittently show a value of “xxx” after start-up or during device operation. an investigation by the manufacturer of the etco2 module has revealed that compressed air may have contaminated filters within in the module. as a result of this filter contamination, the etco2 display on the device will provide a reading of “xxx”. there may be solid or dashed lines present on the device display in the place of an etco2 waveform and the service led will be illuminated. in this situation the etco2 monitoring functionality will no longer be available.
  • 조치
    Physio-Control is advising users who experience the “XXX” after power-up or during device operation to make immediate contact to arrange for servicing of the affected device. Users are further advised that if the issue does not occur, to continue performing the daily device self-tests as indicated in the Operating Instructions and the device is safe to use.

Device

LIFEPAK 15 Monitor/Defibrilators with End-Tidal CO2 (EtCO2) functionality
  • 모델명 / 제조번호(시리얼번호)
    LIFEPAK 15 Monitor/Defibrilators with End-Tidal CO2 (EtCO2) functionalityMultiple Serial NumbersEtCO2 moduleLot Codes: 1506, 1520, 1532, 1544, 1551ARTG Number: 215648
  • Manufacturer
    Physio-Control Australia Pty Ltd

Manufacturer

Physio-Control Australia Pty Ltd
  • 제조사 모회사 (2017)
    Stryker
  • Source
    DHTGA