Events

Sidhil Inspiration Cot 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Midmed 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-00345-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-05-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00345-1
  • 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
    Following a period during which an active child had been left unattended in a 9003 inspiration cot the child was found by a consultancy paediatrician with his top wrapped around his head with the clothing hanging from the cots latch mechanism. the child had lifted up the tubing/cable access latch, which is located on the top rail at the head or foot end of the cot and managed to get his sleeve caught on the latch. upon trying to free himself the child managed to free his arms but was left with his clothing wrapped around his head, with the clothing still being caught on the top of the cot via the latch. the child was freed and no injuries were sustained.
  • 조치
    Midmed is replacing the cable access cot ends with standard cot ends for all cots not used in critical care/intensive care.

Device

Sidhil Inspiration Cot
  • 모델명 / 제조번호(시리얼번호)
    Sidhil Inspiration CotProduct Code: 9003ARTG Number: 167177
  • Manufacturer
    Midmed Pty Ltd

Manufacturer

Midmed Pty Ltd