Events

Newport HT70 and HT70 Plus Ventilators 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-2017-RN-00467-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-04-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00467-1
  • 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
    Medtronic have received reports that newport ht70 and newport ht70 plus ventilators may reset spontaneously during normal operation, without an accompanying alarm. following the reset, the ventilator enters standby mode and will not resume ventilation without intervention. the reported incidence of the reset without alarm condition is approximately one (1) reset in every 7 million hours of ventilation. while the reports indicated that patients required transfer to another ventilator, no patient injury or impairment has been reported. there have been no reports of adverse events in australia.
  • 조치
    Medtronic will provide a software update to resolve the issue, with expected availability end of May 2017. In the interim, an alternative ventilator should be used for patients who are ventilator dependent and have severe lung injury, and all other users should access alternative ventilators where possible and until the corrective actions can be implemented. If the Newport HT70 or Newport HT70 Plus ventilators are to be used, users are to ensure patients on ventilators are appropriately monitored by trained caregivers as described in Operator’s Manual and as detailed in the customer letter.

Device

Newport HT70 and HT70 Plus Ventilators

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