Events

DualHemo Mcable for use with the Infinity Acute Care System (IACS) (Patient monitoring system) 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-2012-RN-01222-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-12-05
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01222-1
  • 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
    There have been reported cases in which the displayed value for the invasive blood pressure measurement of the iacs was lower than the actual patient values were. investigations have shown that liquid ingress in the cable connection of the dualhemo mcable may cause inaccurate measurements. further investigation revealed that this can happen if the dualhemo mcable is used in a non-vertical position or vertically but top down instead of top up, or if it is simply laid down on the floor or on the patient bed and is not adequately positioned.
  • 조치
    Drager Medical GmbH is providing an amendment to the instructions for use describing the correct orientation of the DualHemo Mcable when in use.

Device

DualHemo Mcable for use with the Infinity Acute Care System (IACS) (Patient monitoring system)
  • 모델명 / 제조번호(시리얼번호)
    DualHemo Mcable for use with the Infinity Acute Care System (IACS) (Patient monitoring system)
  • Manufacturer
    Draeger Medical Australia Pty Ltd

Manufacturer

Draeger Medical Australia Pty Ltd