Events

Single Chamber Temporary External Pacemaker 53401 의 안전성 경고

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

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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
    2018-06-22
  • 사례 출판 날짜
    2018-06-22
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180622b.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: medtronic single chamber temporary external pacemaker 53401 medical device manufacturer, medtronic limited, has issued a medical device safety alert concerning its single chamber temporary external pacemaker 53401 [serial numbers lower than mdb05000; distributed between february 2017 and november 2017]. the manufacturer advises users of the potential that a subset of medtronic model 53401 single chamber external pulse generators (epgs) may revert from programmed settings to nominal settings during use with a patient due to an unexpected power on reset (por). the initial version of 53401 epg firmware was configured to allow an unused, unterminated digital input/output pin to be an input. during investigation of the issue, the unterminated pin was found to act as an antenna, which could detect external electrical signals. according to the manufacturer, the 53401 epg microprocessor expects the unterminated pin to be silent. when the unterminated pin detects electrical signals, device firmware may lock up and cause a por. when the epg experiences a por, by design, the device will cease functioning for approximately 7 seconds while it reboots, then resume functioning at nominal settings. through 21 may 2018, there have been 17 confirmed reports of this issue. no patient deaths or complications have been reported as a result of this issue. the manufacturer has received approval for a firmware correction that prevents occurrence of the issue. the affected users are recommended to send affected devices to the manufacturer’s service to update the firmware to prevent the issue. patients being treated with affected 53401 epgs should be continuously monitored per labeled instructions for use. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 22 june 2018.

Device

Single Chamber Temporary External Pacemaker 53401
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Medtronic Single Chamber Temporary External Pacemaker 53401
  • Manufacturer
    Medtronic Limited

Manufacturer

Medtronic Limited
  • 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