Events

PURITTAN BENNET 840 FAN, Anvisa Registration No. 10139810058, Class of Risk: III (High Risk). ## Puritan Bennett 840 fans subject to this Field Action correspond to the manufacturing interval from March 2010 to September 2010 ## SEE Distribution Map (Annex 1). ## 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 AUTO SUTURE DO BRASIL LTDA.; 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
    1395
  • 날짜
    2014-06-25
  • 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
    The company that owns the product registration - AUTO SUTURE DO BRASIL LTDA - recommends: If the loss of the graphical user interface (GUI) is identified, the following measures must be taken in conjunction with the institutional protocols: - Check respiratory stability and psychological aspects of the patient; - Confirm that the patient is receiving respiratory support by observing the expansion and contraction of the patient's chest; - Evaluate the current situation of the patient by analyzing other monitoring (eg, oxygen saturation, heart beat, blood pressure, etc.); - Immediately transfer the patient to an alternative ventilator in a manner consistent with the institutional protocol; - Remove the affected fan from use until it is repaired.
  • 원인
    The field action was triggered by customer reports that reportedly lost information on the graphical user interface (gui) display while the ventilator continues to provide respiratory support. client reports describe that gui display screens (upper and lower) erase during patient use. this event interferes with the physician's ability to see and / or change the fan settings or the alarm parameters set by him. note that in all cases reported so far, the ventilator continues to provide respiratory support during these events. the loss of graphical user interface (gui) display due to power supply failure (psu) is demonstrated by the fan when entering the "gui inop" state, as described below: the puritan bennett 840 fan is designed with one unit (bdu) that works independently of the graphical user interface (gui). both systems actively monitor and communicate with each other as part of normal operations. if the breathing supply unit (bdu) loses communication with the graphical user interface (gui), it recognizes this and enters a "gui inop" mode. it initiates the appropriate alarm consisting of a visible alarm indicated by the red light of the "gui inop" on the breathing supply unit (bdu) and a high priority audible alarm. it should be noted that the fan will continue to operate normally.
  • 조치
    Company holding the registration in Brazil - AUTO SUTURE DO BRASIL LTDA - will make correction in the field and, if necessary, replacement of the Power Supply. ## SEE: 1. Letter to Clients (Annex 2); 2. Traceability Form (Annex 3); 3. Questions and Answers (Annex 4).

Device

PURITTAN BENNET 840 FAN, Anvisa Registration No. 10139810058, Class of Risk: III (High Risk). ## ...

Manufacturer

AUTO SUTURE DO BRASIL LTDA.; 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