Events

Alerta De Seguridad para OXIMAX N-65 PORTABLE PULSE OXIMETER - Register 10349000315 - Hazard Class III (High Hazard) - Models: Nellcor ™ Portable Pulse Oximeters OxiMax ® N-65 and Nellcor ™ Portable Pulse Oximeters OxiMax ® N-560 (Distribution Map attached)

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.; COVIDIEN IIC.

¿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
    1664
  • Fecha
    2015-08-20
  • 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
    SAFETY ALERT: POST should be performed prior to use on patient, as described in the Nellcor ™ OxiMax ® Portable Pulse Oximeters N-65 Operating Manual -65 and Nellcor ™ OxiMax ® N-560 Portable Pulse Oximeters. If during the POST or during the use the absence of any segment in the visualization is observed or if the speaker does not emit sounds, stop the use and contact the company that holds the record. Code FAN560
  • Causa
    Nellcor ™ oximax® n-65 portable pulse oximeters and nellcor ™ oximax® n-560 portable pulse oximeters are not showing complete segments of numerical data (see example in the customer letter), which can lead the end user to a misinterpretation of numerical data. the company points out that the oximetry measurement was not affected, and the problem presented refers solely and exclusively to the numerical demonstration of the display. - letter to clients in annex.
  • Acción
    SAFETY ALERT: POST should be performed prior to use on patient, as described in the Nellcor ™ OxiMax ® Portable Pulse Oximeters N-65 Operating Manual -65 and Nellcor ™ OxiMax ® N-560 Portable Pulse Oximeters. If during the POST or during the use the absence of any segment in the visualization is observed or if the speaker does not emit sounds, stop the use and contact the company that holds the record. Code FAN560

Device

OXIMAX N-65 PORTABLE PULSE OXIMETER - Register 10349000315 - Hazard Class III (High Hazard) - Mod...

Manufacturer

Auto Suture do Brasil Ltda.; COVIDIEN IIC
  • 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