Events

Puritan Bennett 980 Universal Ventilator System 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Medtronic 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
    2018-03-08
  • 사례 출판 날짜
    2018-03-08
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180308b.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 puritan bennett 980 universal ventilator system – tga’s suspension revoked and new suspension in place the therapeutic goods administration (tga) of australia has issued an updated safety alert concerning puritan bennett 980 universal ventilator system, manufactured by medtronic. the original tga’s decision to suspend the pb980 ventilator from the australian register of therapeutic goods (artg), dated 18 september 2017, has been revoked following a review of the decision. however, the review has led to a new decision to suspend the pb980 ventilator from the artg. the suspension is for a period of six months commencing on 5 february 2018. the tga remains concerned that the use of these ventilators has a potential risk of death, serious injury or serious illness. issues that formed the basis for this new suspension were as follows: the current presentation and labelling of the scalar waveform functions of the pb980 ventilator can convey markedly inaccurate values for flow and tidal volume. these values may be different to the ones displayed in the patient data banner; the potential sequelae of relying on those inaccurate flow and tidal volume values as opposed to the values displayed in the patient data banner; and the graphic user interface (gui) is unreliable, because of instances of the screen going blank and the gui becoming unresponsive. according to the local supplier, the affected products are distributed in hong kong. for details, please refer to the tga website: http://www.Tga.Gov.Au/alert/puritan-bennet-980-series-ventilator if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 8 march 2018.

Device

Puritan Bennett 980 Universal Ventilator System
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Medtronic Puritan Bennett 980 Universal Ventilator System
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 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