Events

Compella Air Surfaces Bed System (220 - 240 V, 50 Hz), used in conjunction with International 220 - 240 V, 50 Hz Controllers 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-2017-RN-01388-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-11-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01388-1
  • 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 international (220 - 240 v, 50 hz) compella air surfaces. within the low air loss mattress, a hose in the foot section is prone to kinking and occluding air flow. this can result in heat rising and failure of the air compressor inside the compella controller. if the compressor fails, the controller can no longer function correctly to maintain air flow to the compella mattress, in which case the controller will alarm. to date, there have been no reported patient safety related complaints associated with this issue.
  • 조치
    Hill-Rom is advising users that the affected systems will be corrected as a permanent fix. The systems can continue to be used until the correction has been completed.

Device

Compella Air Surfaces Bed System (220 - 240 V, 50 Hz), used in conjunction with International 220...
  • 모델명 / 제조번호(시리얼번호)
    Compella Air Surfaces Bed System (220 - 240 V, 50 Hz), used in conjunction with International 220 - 240 V, 50 Hz ControllersSerial Numbers: CR600003 to CR604302 and CU200002 to CU200072Manufacturing date range is from March 2015 – March 2017 ARTG Numbers: 239273 and 239274
  • Manufacturer
    Hill-Rom Pty Ltd

Manufacturer

Hill-Rom Pty Ltd