Events

Servo VentilatorsProduct: Servo-n Serial Numbers range: 1240-1455 Product: Servo-u Serial Numbers range: 22611-24876 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Getinge Australia 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-00203-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2018-03-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00203-1
  • 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
    Getinge have identified that under certain conditions, an internal communication error might prevent the safety valve to close automatically. as a consequence, ventilation will stop and a high priority alarm, as well as clinical alarms, will be triggered. getinge are aware of two instances where this issue has caused desaturation but have no reports of resulting permanent injuries.
  • 조치
    Getinge will initiate an immediate update of all affected Servo ventilator units during which the firmware of an internal circuit board will be upgraded. Users will be contacted by their Getinge sales or service representative to plan for the update of the ventilator.

Device

Servo VentilatorsProduct: Servo-n Serial Numbers range: 1240-1455 Product: Servo-u Serial Numbers...
  • 모델명 / 제조번호(시리얼번호)
    Servo VentilatorsProduct: Servo-n Serial Numbers range: 1240-1455Product: Servo-u Serial Numbers range: 22611-24876ARTG Numbers: 218345, 162468(Getinge Australia - Ventilator, neonatal/paediatric)
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

Getinge Australia Pty Ltd