Events

Compella Bariatric Bed System, Controllers and Air Surfaces 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-2016-RN-00745-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-06-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00745-1
  • 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 become aware of a potential issue with some compella air supply units and air surfaces. the compella air supply unit has been prone to inadequate pressure, which prevents the surface from achieving required settings for weight-based pressure redistribution. this also prevents the low air loss feature from operating. in addition, within the low air loss surface, a hose in the foot section is prone to kinking, which can impact airflow to the topper and prevent the proper adjustment of the air bladders to relieve pressure.
  • 조치
    A Hill-Rom representative will be contacting affected facilities to make arrangements for updating the affected capital Compella Air Supply Units and air surfaces. In the interim, Hill-Rom recommends customers to continue to use the product as they normally would. The mattress system will provide an alarm in the event the Compella Air Supply Unit or Air Surface does not operate properly. This action has been closed-out on 18/05/2017.

Device

Compella Bariatric Bed System, Controllers and Air Surfaces
  • 모델명 / 제조번호(시리얼번호)
    Compella Bariatric Bed System, Controllers and Air SurfacesModel Number: P7800ACompella ControllersProduct Number: P7810AManufactured between 25 March 2015 to 11 December 2015Compella Air SurfacesProduct Number: P642AManufactured between 25 March 2015 to 25 September 2015ARTG Numbers: 239273, 239274
  • Manufacturer
    Hill-Rom Pty Ltd

Manufacturer

Hill-Rom Pty Ltd