Events

Affinity Four Birthing Bed 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Hill-Rom 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-00713-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-07-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00713-1
  • 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
    Hill-rom would like to remind users of proper handling of the lift-off foot section per the affinity four birthing bed manual. improper handling, such as allowing the foot section to be dropped repeatedly, could cause the attachment latch mechanism to become bent. if the latch mechanism is bent badly enough, it could potentially cause the installed foot section to be improperly engaged onto the bed. if the damaged foot section should disengage during use, this could result in injury to the user due to a fall.
  • 조치
    Hill-Rom is highlighting key instructions in the operator's manual and providing additional instructions to end users to verify if the Lift-Off foot sections have enough engagement. A change to the Lift-Off foot section is currently in development to mitigate the issue.

Device

Affinity Four Birthing Bed
  • 모델명 / 제조번호(시리얼번호)
    Affinity Four Birthing Bed Part Number: (P3700B/C/D/E)Production dates: October 2006 through June 2014ARTG Number: 151145
  • Manufacturer
    Hill-Rom Pty Ltd

Manufacturer

Hill-Rom Pty Ltd