Events

Retiro De Equipo (Recall) de N'VISION APPLICATION CARD

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por MEDTRONIC OF CANADA 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
    102077
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-03-14
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    The model 8840 physician programmer may display an incorrect "schedule to replace the pump by" date for the model 8637 synchromed ii implantable drug infusion pump. in some circumstances after a pump's eri has occurred the date may be displayed as a series of question marks or as a date greater than 90 days from the eri date potentially leading to the pump reaching end of service prior to replacement. this issue may only occur if the 90days after eri notification falls on the first day of a month. it does not affect pump function or alarms. this is due to a software error specific to the model 8870 application card software for the synchromed ii pump.

Device

N'VISION APPLICATION CARD
  • Modelo / Serial
    Model Catalog: 8870 (Lot serial: Recall is not lot specific)
  • Descripción del producto
    N'VISION APPLICATION CARD
  • Manufacturer
    MEDTRONIC OF CANADA LTD.

Manufacturer

MEDTRONIC OF CANADA LTD.
  • Dirección del fabricante
    BRAMPTON
  • 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
    HC