Events

Contoura 380 and 480 Bed Manufactured between 12 January 2011 to 31 December 2011 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Huntleigh Healthcare 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-2013-RN-00762-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-07-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00762-1
  • 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 investigations by arjohuntleigh it has been determined that the din connector used on these beds has been compromised during the cable manufacturing process. the supplier has determined that liquid droplets have been found inside the male din connector. this substance has been identified as phosphorous that is leaching from the black plastic flame reduction material used in the din connector. the effects of this can lead to a high resistance (ohm) connection between the pins and could result in the beds performing uncommanded movements.
  • 조치
    Customers are requested to remove beds from use and contact the ArjoHuntleigh Service Line immediately if at any time a Contoura 380 or 480 bed performs uncommanded movement. An ArjoHuntleigh Technician will attend each facility to replace any defective DIN connectors. DIN Connectors with production batch date of October or November 2010 will need to be replaced. DIN Connectors with production batch date of January 2011 and February 2011 will undergo a Megger test which will determine if the connector needs to be replaced. This action has been closed-out on 19/05/2016.

Device

Contoura 380 and 480 Bed Manufactured between 12 January 2011 to 31 December 2011
  • 모델명 / 제조번호(시리얼번호)
    Contoura 380 and 480 Bed Manufactured between 12 January 2011 to 31 December 2011ARTG Number: 205117
  • Manufacturer
    Huntleigh Healthcare Pty Ltd

Manufacturer

Huntleigh Healthcare Pty Ltd