Events

Hamilton Medical G5 / S1 Ventilator, software versions between V2.00 and V2.31 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 The Trustee for the Taleb Family Trust T/A Taleb Medical and Vetequip Australia 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-00557-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-05-28
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00557-1
  • 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
    Investigations have shown that ventilation and alarms of a hamilton g5 or hamilton s1 ventilator can be suppressed unintentionally after the activation of a suctioning manoeuvre by the operator. this situation can occur regardless of the selected patient group (neonatal, paediatric, & adult). this vulnerability of the hamilton –g5 and hamilton –s1 exists under specific conditions within an interface prone time window of 50 milliseconds after the ventilator detects a disconnection during a suctioning manoeuvre that has been initiated by operator pressing the o2-enrichment key on the ventilator. this issue could result in the termination of mechanical ventilation and suppression of alarms with the exception of the medium-priority alarm “loss of peep” when peep is set > 4 mbar. please note that the ambient and exhalation valves of the ventilator are opened so that a spontaneously breathing patient can breathe room air unassisted by the ventilator.
  • 조치
    Permanently disable the automated suctioning manoeuvre functionality on all Hamilton G5/ Hamilton S1 ventilators by using a software key provided by the manufacturer. This correction will be undertaken during the preventative maintenance due in June/July 2014. Thia action has been closed-out on 28/01/2016

Device

Hamilton Medical G5 / S1 Ventilator, software versions between V2.00 and V2.31

Manufacturer

The Trustee for the Taleb Family Trust T/A Taleb Medical and Vetequip Australia