Events

Retiro De Equipo (Recall) de Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pre-connect (used in conjunction with Automatic External Defibrillators) Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes

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-2015-RN-00803-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-08-31
  • 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-2015-RN-00803-1
  • 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
    This recall is being conducted due to a low-level potential for damage to the wire insulation which was identified during a review of our manufacturing process. no complaints for this issue have been reported from customers. the use of products with this condition may result in a potentially increased risk for either reduced or no patient therapy, arcing of current, sparking, and potential burns to the patient and/or clinician. no patient injuries have been reported regarding this damaged wire insulation issue.
  • Acción
    Users are asked to immediately quarantine and discontinue use of the affected devices and to arrange return as per the instructions supplied. This action has been closed-out on 31/08/2016.

Device

Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pre-connect (used in conjuncti...
  • Modelo / Serial
    Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pre-connect (used in conjunction with Automatic External Defibrillators)Medi-Trace Cadence Adult Multi-Function Defibrillation ElectrodesItem Numbers: 22550PC, 22770PCLot Numbers: 517521X, 519835X, 516313X, 519124X, 513426X ARTG Number: 186124
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Covidien Pty Ltd

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