Events

CareLink Monitor and CareLink Express Monitor(used to gather information from an implanted heart device and transmit this information to the individual’s healthcare professional) 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-2016-RN-00414-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-04-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00414-1
  • 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
    A recent software update for selected carelink/carelink express monitors included an incorrect telephone number. the telephone number is used when the home monitor is transmitting information to the carelink network. therefore, monitors that have received this update may no longer be able to transmit information, including carealerts, as well as receiving future software updates. the matter does not affect the continued safe operation of an individual’s implant in the immediate term. however if not addressed, a continued inability to connect to the carelink network may cause premature battery depletion for the implant. in a worst case scenario, the reported issue may result in early surgery to replace the implant and/or a reduction in the extended service period.
  • 조치
    For affected clinics/patients, Medtronic will arrange for the delivery of a cellular or internet accessory to connect to the patients’ existing monitor to restore the functionality of the affected units. This action has been closed out on 20/01/2017.

Device

CareLink Monitor and CareLink Express Monitor(used to gather information from an implanted heart ...
  • 모델명 / 제조번호(시리얼번호)
    CareLink Monitor and CareLink Express Monitor(used to gather information from an implanted heart device and transmit this information to the individual’s healthcare professional)Model Numbers: 2020B and 2490CARTG Numbers: 116038 and 193374
  • 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