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
    2016-01-25
  • 사례 출판 날짜
    2016-01-25
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160125a.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 medical device manufacturer, medtronic, has issued a medical device safety alert concerning all models of its puritan bennett 980 (pb980) ventilator for the following two issues: 1. graphical user interface (gui) unresponsive to touch in this situation, the ventilator continues to operate at existing settings, all real-time waveforms and pressure/volume measurements, as well as alarm functions and the bezel keys (hard keys below the touch screen), remain active. however, in this situation, users are unable to change ventilator settings or the configuration of the gui display. should this occur, the clinical team should transfer the patient to another ventilator.The frequency of occurrence based on reported complaints is 1.3%, corresponding to an annual rate of 0.7%. 2. loss of primary ventilation under certain circumstances the manufacturer has received reports of the pb980 ventilator losing primary ventilation capabilities, in which case the backup ventilation (buv) design feature is activated.When buv is initiated, high urgency audio and visual alarms are annunciated immediately and cannot be silenced. the clinical team should transfer the patient to another ventilator. in some cases, the ventilator subsequently progressed to a ventilator inoperative condition, in which case, by design, the ventilator opens all valves to atmospheric pressure and room air, and ventilation ceases. high urgency audio and visual alarms are annunciated. the clinical team should transfer the patient to another ventilator. the manufacturer’s investigation revealed that background diagnostic software responsible for monitoring ventilator system function inappropriately determines a hardware problem exists. the ventilator then moves to buv and occasionally into ventilator inoperative. as stated above, when this occurs the clinical team should transfer the patient to another ventilator. the frequency of occurrence based on reported complaints is 1.6% corresponding to an annual rate of 0.9%. approximately 50% of these events occurred at ventilator power-on/start-up. affected users may continue to use their pb980 ventilators. they are advised to ensure patients on pb980 ventilators are appropriately monitored by medical personnel and suitable monitoring devices as described in the operator’s manual. the manufacturer will develop and implement corrections for these issues. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 january 2016.

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