Events

NeoMode software used on Puritan Bennett 980 Series (PB980) Universal 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-2015-RN-00676-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-07-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00676-1
  • 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 in which tidal volumes reaching patients were lower than set tidal volumes in neonatal volume control plus (vc+) mode with active humidification. this situation may potentially lead to respiratory compromise if not recognised. there have been no serious injuries or deaths related to these reports. covidien’s investigation has identified a software anomaly that contributes to this volume delivery issue in neonatal vc+ mode. this issue has not been observed during neonatal pressure control ventilation, or with paediatric or adult modes of ventilation.
  • 조치
    Covidien will develop and implement a software update for the universal models of ventilators with NeoMode capability. Until that time, Covidien will disable the clinician’s ability to use NeoMode in the PB980 ventilator. A service engineer will be in contact with hospitals to coordinate this process.

Device

NeoMode software used on Puritan Bennett 980 Series (PB980) Universal Ventilator System
  • 모델명 / 제조번호(시리얼번호)
    NeoMode software used on Puritan Bennett 980 Series (PB980) Universal Ventilator SystemARTG 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