Events

Puritan Bennett 980 Series Ventilator System 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-01088-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-10-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01088-1
  • 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
    Normally, if the ventilator is in use and both oxygen and air gas sources are disconnected (leaving the ventilator with no supply of compressed air or oxygen for ventilation of the patient), the ventilator annunciates a high priority “no air supply” and “no o2 supply” alarm. the ventilator then enters a “safety valve open” condition. usually this is immediately recoverable when a gas supply source is reconnected. however, due to a software issue, in some cases the ventilator may transition with a “ventilator inoperative” condition upon reconnection of a gas supply source. during a “ventilator inoperative” condition, the patient is not provided ventilatory support, but may breathe room air spontaneously through the open safety valve. covidien has had no reports of serious patient injury or death associated with this issue.
  • 조치
    A Covidien representative will update the software on affected ventilators as soon as possible. Customers may continue to use the ventilators during this time pending the software correction as long as two gas sources are connected to the ventilator at all times. Covidien is also providing important safety reminders in the customer letter which is described in the Puritan Bennett 980 ventilator operator’s manual. This action has been closed-out on 17/08/2016.

Device

Puritan Bennett 980 Series Ventilator System

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