Events

HAMILTON G5 / S1 ICU ventilators Software versions 2.00X up to 2.31X 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-2014-RN-00556-1
  • 사례 위험등급
    Class I
  • 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-00556-1
  • 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 maneuver by the operator; this situation can occur regardless of the selected patient group (neonatal, pediatric and adult). this vulnerability of the hamilton-g5 and hamilton-s1 exists within an interference-prone time window of 50 milliseconds after the ventilator detects a disconnection during a suctioning maneuver that has been initiated by the operator pressing the o2-enrichment key on the ventilator.
  • 조치
    AHC Solutions is advising operators to always verify that ventilation continues after a suctioning manoeuvre. If ventilation does not continue it can be re-established by pressing the "Manual Breath" key, change the ventilation mode and switch to the "Stand-by Mode" and return to the previously used ventilation mode. AHC Solutionsis advising customer to permanently disable the automated suctioning manoeuvre on all affected ventilators using the software key provided with the customer letter to avoid the issue from occurring. This action has been closed-out on 29/01/2016.

Device

HAMILTON G5 / S1 ICU ventilators Software versions 2.00X up to 2.31X
  • 모델명 / 제조번호(시리얼번호)
    HAMILTON G5 / S1 ICU ventilatorsSoftware versions 2.00X up to 2.31X
  • Manufacturer
    AHC Solutions Pty Ltd

Manufacturer

AHC Solutions Pty Ltd