Infinity Acute Care System (IACS) Monitoring Solution (Patient monitoring system) Software versions VG2.03 and higher are affected 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Draeger Medical Australia 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-01162-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-11-12
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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 manufacturer has found that if a low spo2 yellow medium grade alarm is displayed and paused by the user, the iacs did not generate the spo2 (red) high grade life threatening spo2 low alarm on the cockpit and the central station; only the patient monitor (m540) showed the red signal. the correct spo2 value is indicated on all devices. this iacs behaviour happens only in the neonatal mode.
  • 조치
    Draeger Medical is recommending users not to pause the medium grade SpO2 low alarm without adequate patient surveillance. A software update is being developed as a permanent fix and should be available in March 2014.

Device

  • 모델명 / 제조번호(시리얼번호)
    Infinity Acute Care System (IACS) Monitoring Solution (Patient monitoring system)Software versions VG2.03 and higher are affectedMultiple serial numbers affectedARTG Number: 168054
  • 의료기기 분류등급
  • Manufacturer

Manufacturer