Events

Puritan Bennett 980 Series Ventilator System PB980 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Covidien 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-2016-RN-00089-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2016-02-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00089-1
  • 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
    There have been reports of issues with the graphical user interface (gui) & loss of primary ventilation. the gui can become unresponsive to touch, but the ventilator continues to operate at existing settings, all real-time waveforms, pressure/volume measurements, alarm functions & the bezel keys remain active. however, users are unable to change ventilator settings/configuration of the display. plus, under certain circumstances there is a loss of primary ventilation capabilities, in which the backup ventilation (buv) design feature is activated. when buv is initiated, high urgency audio & visual alarms are enunciated immediately & cannot be silenced. in some cases, the ventilator subsequently progressed to a ventilator inoperative condition, where the ventilator opens all valves to atmospheric pressure & room air, & ventilation ceases. high urgency audio/visual alarms are enunciated. there have been no reports of adverse health effects or death associated with the above situations.
  • 조치
    Covidien is advising users that the continued use of the affected devices is appropriate. However, the decision to continue to use the affected devices should be made in the context of the individual patient’s clinical condition. If the reported defects occur, the clinical team should transfer the patient to anther ventilator. The manufacturer is working on a service update which will be implemented as soon as it becomes available.

Device

Puritan Bennett 980 Series Ventilator System PB980
  • 모델명 / 제조번호(시리얼번호)
    Puritan Bennett 980 Series Ventilator System PB980All models affectedARTG Number: 221416
  • 의료기기 분류등급
    Anesthesiology Devices
  • Manufacturer
    Covidien Pty Ltd

Manufacturer

Covidien Pty Ltd
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA