Events

Power cord used on BioConsole, autoLog, Sequestra 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Cardiovascular Revascularization & Surgical Therap 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
    55749
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1939-2010
  • 사례 시작날짜
    2010-04-21
  • 사례 출판 날짜
    2010-06-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-12-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91714
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    power cord on cardiopulmonary bypass - Product Code DWA
  • 원인
    The potential risks during the use of this power cord include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires. although medtronic has received no reports of adverse events related to the affected cord, a failure may potentially lead to serious adverse health consequences, depending on the device, and therapy being interrupted. this field notificatio.
  • 조치
    Consignees were sent on 4/21/10 a Medtronic "Urgent Medical Device Recall Notice" letter dated April 19, 2010. The letter was addressed to their customers and described the problem and the product involved. They recommended to discontinue use of the AC power cords and to destroy them. Requested consignees to fill out the attached Medtronic Recall Certificate (FCA 1005), and return it to Medtronics.

Device

Power cord used on BioConsole, autoLog, Sequestra
  • 모델명 / 제조번호(시리얼번호)
    Part # 66319 & 055476
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA, Latin America, Middle East, Japan, and Canada.
  • 제품 설명
    Hospital Grade Power Cord, UL, Part # 66319, 055476, manufactured by Electri-Cord Manufacturing Co. beginning in February 2003. The cords are a detachable unit, supplied with the instruments listed below: || Medtronic Bio-Console¿ 550 centrifugal pump console, Model #95180, Catalogue # 95180, E95180, R95180. || Medtronic Bio-Console¿ 560 centrifugal pump consoles Model # 560BC, Catalogue # 560BC, 560BCS, 560BCS1. || Medtronic autoLog¿, Model # ATLG110, Catalogue # ATLG110, ATLG110E || ATLG110R. || Medtronic Sequestra¿ 1000, Model #SEQ1000, Catalogue # SEQ1000, SEQ1000E, SEQ1000R.
  • Manufacturer
    Medtronic Cardiovascular Revascularization & Surgical Therap

Manufacturer

Medtronic Cardiovascular Revascularization & Surgical Therap
  • 제조사 주소
    Medtronic Cardiovascular Revascularization & Surgical Therap, 7611 Northland Dr N, Brooklyn Park MN 55428-1088
  • 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
    USFDA