Events

Kendall 1010P Multi-Function Defibrillation Electrodes & Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Covidien LLC 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
    2014-09-29
  • 사례 출판 날짜
    2014-09-29
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140929a.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: covidien llc kendall 1010p multi-function defibrillation electrodes & medi-trace cadence adult multi-function defibrillation electrodes the australia therapeutic goods administration (tga) and the health canada posted medical device safety alerts concerning kendall 1010p multi-function defibrillation electrodes [model no.:22660pc, 22660r] & medi-trace cadence adult multi-function defibrillation electrodes [model no.: 40000006] manufactured by covidien llc. according to the medical device safety alerts, there was incompatibility between the philips automated external defibrillators (aed) models fr3 and frx defibrillators and covidien medi-trace cadence and kendall defibrillation electrodes. these electrodes will not connect with philips fr3 and frx aed units, and in the case of the use of covidien defibrillation electrodes with the philips fr3 aed units, could result in a delay of therapy. the frx aed unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads are not connected to the unit prior to use. the manufacturer is modifying the labeling to clarify that use of the affected electrodes are incompatible with certain aed units. for details, please refer to the following health canada and tga websites: http://www.Healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2014/41547r-eng.Php http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-01034-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 29 sep 2014.

Device

Kendall 1010P Multi-Function Defibrillation Electrodes & Medi-Trace Cadence Adult Multi-Function ...
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Cardiovascular Devices
  • 제품 설명
    Medical Device Safety Alert: Covidien LLC Kendall 1010P Multi-Function Defibrillation Electrodes & Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes
  • Manufacturer
    Covidien LLC

Manufacturer

Covidien LLC
  • 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