Events

Carestation 620 A1, 650 A1, and 650c A1 Anaesthesia devices and service kits 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 GE Healthcare 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-2016-RN-00143-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2016-02-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00143-1
  • 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
    Ge healthcare has recently become aware of a potential safety issue with the btv switch of certain carestation 600 series anaesthesia systems. the btv switch could become difficult to move between mechanical ventilation and manual bag modes or remain in a position where it is not possible to ventilate the patient using the anaesthesia system. this issue could result in loss of patient ventilation potentially resulting in hypoxia. there have been no customer complaints or injuries reported as a result of this issue.
  • 조치
    GE Healthcare is advising users that the systems can continued to be used. However users should ensure back up ventilation, independent of the anaesthesia machine is available. GE is advising users all affected devices will be corrected.

Device

Carestation 620 A1, 650 A1, and 650c A1 Anaesthesia devices and service kits
  • 모델명 / 제조번호(시리얼번호)
    Carestation 620 A1, 650 A1, and 650c A1 Anaesthesia devices and service kitsSerial Numbers: Carestation 620 A1 (GTIN: 00840682103985): SM615020004WA to SM616010008WACarestation 650 A1 (GTIN: 00840682103947): SM715020005WA to SM716010008WACarestation 650c A1 (GTIN: 00840682103954): SM815020001WA to SM815500001WAService kits affected2071003-001-S , BTV SWITCH ASSEMBLY2081000-001-S , ASSY BOTTOM BC2082466-001-S, ASSY BOTTOM BC AUS FEMALE 22ARTG Number: 93955
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd