Events

Puritan Bennett 840 Ventilator 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-2014-RN-00618-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-06-05
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00618-1
  • 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
    Covidien has received customer reports of the loss of graphical user interface (gui) display information while the ventilator continues to provide breath support. customer reports describe the gui display screens (both upper and lower) becoming blank during patient use. this event interferes with the clinician's ability to view and/or change ventilator setting or clinician-set patient alarm parameters. loss of gui display due to a power supply unit (psu) failure is demonstrated by the ventilator entering a “gui inop” state i.E., if the breath delivery unit (bdu) loses communication with the gui, the bdu recognises this and enters a “gui inop” state. it initiates the appropriate alarm consisting of a visible alarm indicated by the illumination of the “gui inop” red light on the bdu and a high-priority audible alarm. the source of the psu voltage loss is a specific circuit responsible solely for the gui central processing unit voltages.
  • 조치
    A Covidien representative will perform an inspection of affected ventilator(s) to determine if it has the affected component and if so, will replace defective PSU immediately. If users encounter a loss of display, they are advised to verify the patient’s respiratory and physiological stability ie, confirm the patient is receiving ventilatory support by observation of the expansion and contraction of the patient’s chest and assess current patient status by review of other monitoring (e.g., oxygen saturation, heart rate, blood pressure, etc). Also, users are advised to promptly transfer the patient to an alternate ventilator in a manner consistent with the institutional protocol and remove the affected ventilator from use until it has been serviced. This action has been closed-out on 02/02/2016.

Device

Puritan Bennett 840 Ventilator
  • 모델명 / 제조번호(시리얼번호)
    Puritan Bennett 840 VentilatorPower Supply Serial Numbers: 39302, 40221, 40355, 40465, 40324, 40327, 40450Vent Serial Numbers: 3510102854, 3510102868, 3510102839, 3510102853, 3510102849, 3510102848, 3510102852ARTG Number: 182309
  • 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