Events

Hamilton Galileo Ventilator when used with Flexport Communication Interface Protocol version 1.2 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Medtel 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-2014-RN-00582-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-05-29
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00582-1
  • 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
    The monitored minute volumes (vmin) are reported at ten times actual value on the bedside monitor. the source of this error is associated with a change in the flexport communication protocol between versions 1.1 and 1.2. all alarms and setting levels on the bedside monitor continue to perform properly and are unaffected by this error. the reported x10 volumes would be an obvious error to the clinician.
  • 조치
    Medtel Australia is notifying their customers of the issue and advising that the ventilator performance is not affected. A software update will be implemented to correct the issue. This action has been closed-out on 12/02/2016.

Device

Hamilton Galileo Ventilator when used with Flexport Communication Interface Protocol version 1.2
  • 모델명 / 제조번호(시리얼번호)
    Hamilton Galileo Ventilator when used with Flexport Communication Interface Protocol version 1.2Model Number: 90436A-07ARTG Number: 135706
  • Manufacturer
    Medtel Pty Ltd

Manufacturer

Medtel Pty Ltd
  • Source
    DHTGA