Events

** Trade Name: VENTILATION SYSTEM 840 ** - Registration: 10139810058 ** - Expiry Date: 05/15/2015 ** - Hazard Class: III - HIGH RISK ** - Model 4-070205-85 ** - Attached Series of products under risk in Brazil 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 NELLCOR PURITAN BENNETT IRELAND 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
  • 사례 ID
    1338
  • 날짜
    2013-12-05
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • 데이터 추가 비고
    If one of your Puritan Bennett ™ 840 ventilators displays the problem code (XB0069), it can no longer be used until serviced, which includes turning the device off and on, and rotate EST. In addition, when using the ventilator on a patient, always follow the instructions as described in the Puritan Bennett ™ 840 Operator's Manual: a) Patients on life support equipment should be adequately monitored by appropriate medical staff and appropriate monitoring devices ( Preface); * b) An alternate source of ventilation should always be available when using a critical care ventilator (Preface); * c) When using the fan volume selectable volume range, be sure to select an alarm volume level that can be differentiated from the background noise levels (Section 5.5).
  • 원인
    Due to a product software error, mechanical ventilation may be interrupted.
  • 조치
    The company is conducting a corrective action security field upgrade software. * Attached is the document in the form of "Questions and Answers" made available by the company - Customer Verification Form - Notice to the services

Device

** Trade Name: VENTILATION SYSTEM 840 ** - Registration: 10139810058 ** - Expiry Date: 05/15/2015...

Manufacturer

NELLCOR PURITAN BENNETT IRELAND
  • 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
    ANVSANVISA