Events

Philips V60 non-invasive ventilatorAll ventilators with a date of manufacture prior to15 September 2015 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Philips Electronics Australia 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-2017-RN-00650-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-05-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00650-1
  • 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
    Philips has identified an issue with an internal cable of the philips v60 non-invasive ventilator manufactured prior to 15 september 2015. over time, low-frequency vibrations can cause the pins within the female connectors on the internal motor controller to data acquisition board ribbon cable to become partially displaced, which causes momentary high resistance that interferes with data transfer. this may cause the ventilator to fail power on self testing (post) or cause continuous built in test (cbit) to detect a fault and lead to a ventilator shut down with alarm during use or during intra-hospital transport.If a vent inop event occurs when a patient is connected, pressure support and o2 delivery will cease. such cessation may cause the patient’s spo2 to drop and, if the alarm is not attended to promptly, may lead to hypoxemia or hypercarbia.There have been two reported deaths and nine reports of harm/injury from overseas jurisdictions.
  • 조치
    To minimise risks of illness or injury, users are requested to operate the V60 as directed or recommended in the operator’s manual, including by: · Promptly attending to all alarms presented by the V60 Ventilator; · Using an external O2 monitor/analyser and setting the alarm thresholds appropriately; · Ensuring the correct circuits and masks identified in the operator’s manual are used with the V60; · Wherever possible, connecting the V60 to a remote call system; and If the V60 Shuts down, alarms, and displays any of the error codes 100A, 1006, 1007, or 1008, then (i) turn the V60 off, (ii) discontinue use of the V60, and (iii) use an alternate ventilator. Call your local customer service contact and report the failure. Please reference FCO86600037A. The incidence of failure is low but there is significant risk if it occurs. In deciding whether to continue using the V60, facilities should consider their monitoring and response capabilities or an alternative ventilator.

Device

Philips V60 non-invasive ventilatorAll ventilators with a date of manufacture prior to15 Septembe...

Manufacturer

Philips Electronics Australia Ltd
  • 제조사 모회사 (2017)
    Philips
  • Source
    DHTGA