Events

Welch Allyn Propaq LT / Propaq 802 with Nellcor SpO2 (multifunction patient monitor) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Welch Allyn Australia Pty Limited 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-2013-RN-01124-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-11-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01124-1
  • 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
    Internal product testing conducted by welch allyn has identified fault conditions relating to electrical noise caused by proximal defibrillation activity that could, in rare instances, potentially interrupt propaq lt device operations. if this event were to occur, the device would either present an error screen instructing the user to restart the monitor, or could instead present a blank or white screen. either screen would be accompanied by one or more blinking led lights, and in either case, the issue would be resolved by restarting (power cycling) the monitor. this issue is more likely to occur at higher energies such as 5kv. there is no risk associated with this issue other than a very short delay in obtaining patient vital signs from the propaq lt while the device is restarted.
  • 조치
    Welch Allyn is providing work around instructions for users to follow if the error messages are displayed. A software update will be implemented to permanently correct the issue.

Device

Welch Allyn Propaq LT / Propaq 802 with Nellcor SpO2 (multifunction patient monitor)
  • 모델명 / 제조번호(시리얼번호)
    Welch Allyn Propaq LT / Propaq 802 with Nellcor SpO2 (multifunction patient monitor)Model Numbers: 802LTAN, 802LT0NSerial Numbers: KA009946 to KA027084 and KL014918 to KL019440ARTG Number: 123809
  • Manufacturer
    Welch Allyn Australia Pty Limited

Manufacturer

Welch Allyn Australia Pty Limited