Events

Siesta i TS machine(P/N # 866163/10653-00) with a serial number within the following range:200550022 to 200949001AM5153237 to AM5156683DK25100001 to DK43000256 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Proact Medical Systems (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-2015-RN-00707-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-08-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00707-1
  • 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 internal review, philips identified that it was not explicitly described in the instructions for use that the o2 test must be done as part of the daily check to ensure that the machine measures the o2 concentration in the fresh gas correctly, and can deliver the desired o2 concentration in the fresh gas to the patient.Incorrect measurement of o2 concentration in the fresh gas or o2 concentration in the fresh gas not at desired level, can potentially cause hypoxia to the patient.
  • 조치
    Review the Recall for Product Correction and the update to the IFU and ensure that the changes are understood and that all personnel using the device are informed about the content in this Recall for Product Correction. This action has been closed-out on 17/08/2016.

Device

Siesta i TS machine(P/N # 866163/10653-00) with a serial number within the following range:200550...
  • 모델명 / 제조번호(시리얼번호)
    Siesta i TS machine(P/N # 866163/10653-00) with a serial number within the following range:200550022 to 200949001AM5153237 to AM5156683DK25100001 to DK43000256ARTG Number: 176848
  • Manufacturer
    Proact Medical Systems (Australia) Pty Ltd

Manufacturer

Proact Medical Systems (Australia) Pty Ltd