Events

Pressure Display Box (66000, 64000, 63000, 60000) with Pressure Display Set (Models 61000, 61006, 62000, 62006) 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Medtronic 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
    2011-11-28
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111128.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
    Field safety notice: medtronic pressure display box (66000, 64000, 63000, 60000) with pressure display set (models 61000, 61006, 62000, 62006) medical device manufacturer, medtronic inc. has issued a field safety notice concerning pressure display box, model 66000, with disposable pressure display set (models 61000, 61006, 62000, 62006). the notice intended to inform users about the clarification related to the directions of use (dfu) provided with the product according to medtronic, the display reading of the press display box may vary more than +/- 5mmhg from actual line pressure during use in the -40 to -100mmhg range, which is different from the figure stated in the dfu. previous pressure display boxes which may still be in use (models 60000, 63000 and 64000) 64000), do not include accuracy information beyond -50 mmhg for negative pressure in their dfu, but are expected to perform similarly to the model 66000. besides, medtronic clarified that the intended use of the disposables is only for cardiopulmonary bypass surgery (procedures up to 6 hours). use beyond 6 hours may result in air leakage in the system resulting in an inaccurate pressure reading. medtronic intends to update the directions for use (dfu) provided with the products to address the abovementioned issues. according to the local supplier, the device has been distributed in hong kong, and they are in the process of notifying the affected customers. if you are in possession of the affected products, please contact your supplier for necessary actions.

Device

Pressure Display Box (66000, 64000, 63000, 60000) with Pressure Display Set (Models 61000, 61006,...
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Medtronic Pressure Display Box (66000, 64000, 63000, 60000) with Pressure Display Set (Models 61000, 61006, 62000, 62006)
  • Manufacturer
    Medtronic Inc.

Manufacturer

Medtronic 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