Events

F & P SleepStyle CPAP Device Devices using V1.1.0 firmware 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Fisher & Paykel Healthcare 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-00250-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2018-03-29
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00250-1
  • 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
    Fisher & paykel healthcare has identified a firmware anomaly which prevents the fisher & paykel sleepstyle from recording clinical data, and may delay remote prescription changes if the device is continually powered for 20-50 days. this time frame may vary depending on the number and length of therapy sessions. the firmware anomaly does not prevent the ongoing delivery of currently prescribes setting and therapy does not affect any other functions of the device. only devices with v1.1.0 firmware are affected.To date, no complaints resulting in injury have been received relating to this issue.
  • 조치
    Fisher and Paykel will be contacting distributors, hospitals and retailers to arrange for hardware upgrade to be installed in affected units. For devices currently used in a home setting, this action does not impact products with activated modem capabilities. For affected product without modems, have non-activated modems or modems out of service, continuous data recording can be ensured by reminding users to follow instructions in the SleepStyle Use and Care guide to unplug and clean the device every 7 days.

Device

F & P SleepStyle CPAP Device Devices using V1.1.0 firmware
  • 모델명 / 제조번호(시리얼번호)
    F & P SleepStyle CPAP Device Devices using V1.1.0 firmwareModel Number; SPSAAA, SPSCAABatch Numbers: SPSAAA: 2100199626 - 2100401417SPSCAA: 2100194431 - 2100302650ARGT Number: 227979 (Fisher & Paykel Healthcare - OSA CPAP Therapy devices - Home CPAP unit)
  • Manufacturer
    Fisher & Paykel Healthcare Pty Ltd

Manufacturer

Fisher & Paykel Healthcare Pty Ltd