Events

Universal Arm Support Product Names: Universal Arm Support 450 / 450T, 600 / 600T, 450U / 450U T 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-2018-RN-00217-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-03-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00217-1
  • 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
    During continuous monitoring and analysis of trumpf medical products installed in the field, some customers have reported that the universal arm support may be unable to hold its set position and support the arm of the patient. investigations indicates this is typically seen prior to initial use or during set-up, but the clamping could also deteriorate over time. the product has not been involved with any reported injuries.
  • 조치
    Trumpf Medical is advising users to confirm all mechanical functions are parts are undamaged and in good working order prior to each use as outlined in the IFU. In cases where it is identified that the device is defective, damaged, leaking oil or will not hold its set position, stop use of the device and contact Trumpf Medical: service.au@trumpfmedical.com to receive the replacement parts. Please ensure replaced part sare returned to Trumpf Medical.

Device

Universal Arm Support Product Names: Universal Arm Support 450 / 450T, 600 / 600T, 450U / 450U T
  • 모델명 / 제조번호(시리얼번호)
    Universal Arm Support Product Names: Universal Arm Support 450 / 450T, 600 / 600T, 450U / 450U TModel Numbers: 1697630, 1697635, 1697639, 1697651, 1697660, & 1697662.Serial Numbers up to (respectively): 103106579, 103011318, 102631713, 102968819, 102956866, 102945650Manufactured between May 2012 and Aug 25 2016ARTG Number: 296295Trumpf Med Aust - Holder, patient, arm
  • Manufacturer
    Trumpf Med Aust Pty Ltd

Manufacturer

Trumpf Med Aust Pty Ltd