Events

HeartWare HVAD Controller AC Adapter and HeartWare HVAD Battery 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 HeartWare Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2015-12-28
  • 사례 출판 날짜
    2015-12-28
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151228a.html
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: heartware hvad controller ac adapter and heartware hvad battery the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning heartware hvad controller ac adapter and heartware hvad battery manufactured by heartware inc. the affected products are identified as follows: controller ac adapter: product code: 1430xx; serial numbers: cac000001 to cac005796 hvad battery: product code: 1650xx and a00035; serial numbers: bat000001 to bat199999 according to the alert, heartware ac adapters with the above serial numbers are vulnerable to power grid surges above 220 volts. if an ac adapter fails, the patient’s controller will alarm and automatically switch to the other power source. if patients follow the manufacturer’s patient manual, there are no elevated risks to health. however, if a patient is not connected to two power sources, or if the second power source is insufficient to power the system during the time that it takes to replace a failed ac adapter, the system could lose power, which may lead to serious injury or death. there have been complaints related to earlier than expected battery depletion for batteries with serial numbers bat000001 to bat199999. premature or unrecognised battery depletion may pose a risk to the patient, if the patient is not connected to two power sources, or if the second power source is insufficient to power the system during the time that it takes to replace a depleted battery. the manufacturer is advising healthcare professionals to identify and quarantine the affected units in hospital inventory and arrange for current patients to bring their ac adapters and batteries to a clinic as soon as possible (at least within the next three months), with urgency dependent upon individual patient circumstances. for details, please refer to the tga website:http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2015-rn-01261-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 december 2015.

Device

HeartWare HVAD Controller AC Adapter and HeartWare HVAD Battery
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: HeartWare HVAD Controller AC Adapter and HeartWare HVAD Battery
  • Manufacturer
    HeartWare Inc

Manufacturer

HeartWare Inc
  • 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
    DH