Events

Alerta De Seguridad para 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). ##

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por AUTO SUTURE DO BRASIL LTDA.; NELLCOR PURITAN BENNETT IRELAND.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1395
  • Fecha
    2014-06-25
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    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.
  • Causa
    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.
  • Acción
    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
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “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