Events

Retiro De Equipo (Recall) de Newport HT70 and HT70 Plus Ventilators

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Covidien Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2017-RN-00467-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-04-12
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00467-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Medtronic have received reports that newport ht70 and newport ht70 plus ventilators may reset spontaneously during normal operation, without an accompanying alarm. following the reset, the ventilator enters standby mode and will not resume ventilation without intervention. the reported incidence of the reset without alarm condition is approximately one (1) reset in every 7 million hours of ventilation. while the reports indicated that patients required transfer to another ventilator, no patient injury or impairment has been reported. there have been no reports of adverse events in australia.
  • Acción
    Medtronic will provide a software update to resolve the issue, with expected availability end of May 2017. In the interim, an alternative ventilator should be used for patients who are ventilator dependent and have severe lung injury, and all other users should access alternative ventilators where possible and until the corrective actions can be implemented. If the Newport HT70 or Newport HT70 Plus ventilators are to be used, users are to ensure patients on ventilators are appropriately monitored by trained caregivers as described in Operator’s Manual and as detailed in the customer letter.

Device

Newport HT70 and HT70 Plus Ventilators

Manufacturer

Covidien Pty Ltd
  • 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
    DHTGA