Events

GETINGE EDS8 (Endoscope Drying and Storage Cabinet) Compressor 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-00906-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-07-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00906-1
  • 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 an issue which may result in a lack of drying/storage of restrictive endoscopes when they are placed in the eds8. this potential for malfunction is caused by a device design issue. it is identified that the delivered pressure and flow rate of the eds8 compressor is too low. under certain conditions (drying/storage of a restrictive endoscope), the compressor may not be powerful enough to reach the 5l/min airflow required to properly dry/store the endoscopes.Getinge have received several complaints related to this issue, but there was no reported user or patient injury.
  • 조치
    Getinge have developed a compressor with a higher flowrate to correct this issue. Getinge will contact users to arrange replacement of the current compressor.

Device

GETINGE EDS8 (Endoscope Drying and Storage Cabinet) Compressor
  • 모델명 / 제조번호(시리얼번호)
    GETINGE EDS8 (Endoscope Drying and Storage Cabinet) Compressor Model Numbers: 01039717 – Right hinge EDS8-R and 01039716 – Left hinge EDS8-L ARTG Number: 276061(Getinge Australia Pty Ltd - Endoscope drying/storage chamber)
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

Getinge Australia Pty Ltd