Events

Ceiling Supply Unit klinoPORTklinoPORT 706 M, 806 M, 906 M , 1006 M, 1306M 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Trumpf Med Aust 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-2015-RN-00590-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-07-02
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00590-1
  • 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
    Trumpf medical has been notified of an incident where a motorised height-adjustable arm of a klinoport ceiling supply unit suddenly and abruptly fell to its lowest position. the cause analysis revealed that the welded connections of the drive did not comply with the specified condition and therefore led to breakage of these connections. it is currently not to be ruled out that further drives within the same serial numbers range may have the same fault. if further cases should occur, the risk of severe injury to persons cannot be ruled out.
  • 조치
    Trumpf Medical will replace all potentially affected components in order to prevent a repetition of this incident. Until the correction can be made end users are advised to ensure that the unit is in the lowest position. Trumpf is recommending that a warning be placed on the device or the electrical fuse removed to ensure that the height of the arm is not adjusted. This action has been closed-out on 08/08/2016.

Device

Ceiling Supply Unit klinoPORTklinoPORT 706 M, 806 M, 906 M , 1006 M, 1306M
  • 모델명 / 제조번호(시리얼번호)
    Ceiling Supply Unit klinoPORTklinoPORT 706 M, 806 M, 906 M , 1006 M, 1306MItem Numbers: 4027210, 4027410 and 4027510Serial Numbers: 100775185 to 101040245Only motorised height-adjustable arms are affected by this recall (recognisable by the letter "M" in the product name)
  • Manufacturer
    Trumpf Med Aust Pty Ltd

Manufacturer

Trumpf Med Aust Pty Ltd