Events

HAMILTON-T1 Transport Ventilator, Software version 1.1.2 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 AHC Solutions 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-2013-RN-00025-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-01-10
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00025-1
  • 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
    Higher than expected internal oxygen consumption of the hamilton t1 transport ventilator may cause miscalculation of the required oxygen supply for paediatric patient transport situations with long timeframe applications where the oxygen supply may be limited or finite.
  • 조치
    AHC Solutions Pty Ltd (the sponsor) is providing amended instructions describing the process required to calculate the correct oxygen requirement prior to transport. Hamilton Medical (the manufacturer) will provide a software update to correct the issue.

Device

HAMILTON-T1 Transport Ventilator, Software version 1.1.2
  • 모델명 / 제조번호(시리얼번호)
    HAMILTON-T1 Transport Ventilator, Software version 1.1.2Model Number: T1Multiple serial numbers affectedARTG Number: 187874
  • 의료기기 분류등급
    Anesthesiology Devices
  • Manufacturer
    AHC Solutions Pty Ltd

Manufacturer

AHC Solutions Pty Ltd