Events

Alerta De Seguridad para ** 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

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por 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
    1338
  • Fecha
    2013-12-05
  • 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
    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).
  • Causa
    Due to a product software error, mechanical ventilation may be interrupted.
  • Acción
    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
  • 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