Events

Rechargeable Li-Ion Batteries with incorrect firmware used in Puritan Bennett 980 Ventilators 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Medtronic Australasia 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-01429-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-11-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01429-1
  • 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 has identified specific units of lithium ion batteries which are used in puritan bennett 980 ventilators, following reports that the batteries may not fully charge after installation. the scope of this notice includes batteries that were manufactured between december 2013 and may 2017, with serial numbers begin with 1201xxxxxx through 1712xxxxxxa functional battery installed in the pb980 ventilator automatically recharges when the battery depletes and the ventilator is connected to ac power. in the case of a battery with incorrect firmware, it may fail to fully charge. this situation does not impact the ventilator’s operation when it is connected to ac power. however, if the ventilator is operated on battery power alone, this situation could limit the amount of time the ventilator is operational.
  • 조치
    Notify all care environments in which the PB980 ventilators are used about this notification. If PB980 ventilators have been distributed to other persons or facilities, promptly forward a copy of this letter to them. Complete the attached form and return it as directed to confirm your receipt and understanding of this information. Medtronic service engineers will inspect batteries in the field during scheduled or preventive maintenance. Batteries found to have the incorrect firmware will be replaced. The PB980 ventilator may continue to be used as described in the Operator’s Manual.

Device

Rechargeable Li-Ion Batteries with incorrect firmware used in Puritan Bennett 980 Ventilators
  • 모델명 / 제조번호(시리얼번호)
    Rechargeable Li-Ion Batteries with incorrect firmware used in Puritan Bennett 980 VentilatorsProduct Code: 10086042Serial Numbers beginning with 1201xxxxx through 1712xxxxxxARTG Number: 221452
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia 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