Events

HeartWare Ventricular Assist System Batteries 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
    2014-05-08
  • 사례 출판 날짜
    2014-05-08
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140508.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 ventricular assist system batteries the australia therapeutic goods administration (tga) posted a medical device safety alert concerning heartware ventricular assist system batteries manufactured by heartware inc. the affected product code is 1650. all heartware battery serial numbers are affected. the manufacturer has seen an increase in complaints related to both premature battery failure and routine battery handling. premature or unrecognised deterioration of battery capacity or lapses in recommended power management pose a risk to the patient and, although rare, may result in serious injury or death. early recognition of premature battery depletion, patient training and close attention to recommended power management practices are crucial to reduce patient risk. therefore, the manufacturer is providing patients and health professionals with information to recognise batteries with less than two hours of run time, re-emphasise instruction on actions to take when battery alarms occur and reinforce proper power management. the manufacturer is closely monitoring the complaints to ensure that the heartware system functions as intended and to assess the effectiveness of the field correction. the manufacturer will continue to investigate prematurely depleting batteries and will take additional actions as appropriate. for details, please refer to tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-00510-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 08 may 2014.

Device

HeartWare Ventricular Assist System Batteries
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: HeartWare Ventricular Assist System Batteries
  • 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