Events

Giraffe Stand Alone Resuscitation Systems with Blender, Giraffe Warmer Integrated Resuscitation systems with Blender, Panda Warmer Integrated Resuscitation systems with Blender, Panda Freestanding Warmer Integrated Resuscitation Systems with Blender, Resuscitation System field upgrade kits with Blender 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-2013-RN-01334-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-12-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01334-1
  • 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 associated with the loosening of the blender knob shaft on all resuscitation units. a loose blender knob shaft may potentially affect the accuracy of the blended output of air/oxygen gas mixture from the unit which could result in hypoxia or hyperoxia.
  • 조치
    GE Healthcare is advising users to perform a blender accuracy check as outlined in the service manual to verify the O2 concentration set at 21% and 100% settings are within the recommended range. If the blender accuracy test results do not meet specification, remove from patient use and contact GE Healthcare. If the blender accuracy results pass, the system is suitable for continued use, however GE is recommending that when delivering oxygen a pulse oximeter is used to monitor the patient. GE Healthcare will be correcting all affected systems as a permanent fix.

Device

Giraffe Stand Alone Resuscitation Systems with Blender, Giraffe Warmer Integrated Resuscitation s...
  • 모델명 / 제조번호(시리얼번호)
    Giraffe Stand Alone Resuscitation Systems with Blender, Giraffe Warmer Integrated Resuscitation systems with Blender, Panda Warmer Integrated Resuscitation systems with Blender, Panda Freestanding Warmer Integrated Resuscitation Systems with Blender, Resuscitation System field upgrade kits with BlenderARTG Number: 139290
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd