Events

Notificaciones De Seguridad De Campo acerca de Newport™ HT70 and Newport™ HT70 Plus Ventilators

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Medtronic.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    The purpose of this letter is to advise you that medtronic is issuing a field safety corrective action (fsca) for all its newport™ ht70 and newport™ ht70 plus ventilators following reports that the ventilator may, on rare occasion, reset spontaneously during normal operation without an accompanying alarm. while the reports indicated that patients required transfer to another ventilator, no patient injury or impairment has been reported. the reported incidence of the reset without alarm condition is approximately one (1) reset in every 7 million hours of ventilation. following the reset, the ventilator enters standby mode and will not resume ventilation without intervention. based on our internal review, including the low rate of incidence for this issue, medtronic is advising that you may continue to use your newport™ ht70 series ventilators in accordance with institutional policies and as described below. .

Device

Newport™ HT70 and Newport™ HT70 Plus Ventilators

Manufacturer

Medtronic
  • 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
    AMPMDRS