Events

Retiro De Equipo (Recall) de NIM-ECLIPSE Notebook Computer, NCCPU-E4(Part of the NIM-ECLIPSE System used for neurovascular monitoring during intraoperative and ICU applications)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medtronic Australasia 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-2016-RN-00247-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2016-03-08
  • 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-2016-RN-00247-1
  • 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
    Two laptops returned from medtronic japan distribution centre alleged a power supply issue. the defective power supply could impact the performance of the gui by introducing latency (delay) in its performance. however, once the units are turned on while connected to their respective power supplies (dell 90 watt ac adapters), the users would be warned by the "ac alert message" that is shown on the screen during the boot up process. this issue is unlikely to present a hazard to either the patient or the user. there have been no complaints or adverse events reported for this issue from the field.
  • Acción
    Medtronic will replace the affected power supply units with unaffected stock. This action has been closed-out on 27/01/2017.

Device

NIM-ECLIPSE Notebook Computer, NCCPU-E4(Part of the NIM-ECLIPSE System used for neurovascular mon...
  • Modelo / Serial
    NIM-ECLIPSE Notebook Computer, NCCPU-E4(Part of the NIM-ECLIPSE System used for neurovascular monitoring during intraoperative and ICU applications)Lot / Batch numbers: X06016674, X06016675, X06018893, X06026959,X06026960, X06026961, X06026962, X06026963,X06040001, X06040002, X06042171, X06042172,ARTG number: 169810
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia 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