Events

Hill-Rom MC700 General Ward 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-00537-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-05-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00537-1
  • 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 has found that some of the hill-rom mc700 general ward beds, manufactured between the dates specified, may experience problems with the brakes; if the brake system is not fully engaged upon activation, the brakes may become disengaged when the bed is shaken. this can result in unwanted bed movement, and possible patient or caregiver injury.
  • 조치
    Hill-Rom is advising their customers to ensure that beds are monitored for brake malfunction. If a brake malfunction is observed remove the bed from service. Hill-Rom is currently working on a long term correction which will be installed on all affectd beds once complete. This action has been closed-out on 17/08/2016.

Device

Hill-Rom MC700 General Ward Bed
  • 모델명 / 제조번호(시리얼번호)
    Hill-Rom MC700 General Ward BedSerial Numbers: 006505 to 009144Manufactured from Jan 2012 to Feb 2014ARTG Number: 170974
  • Manufacturer
    Hill-Rom Pty Ltd

Manufacturer

Hill-Rom Pty Ltd