Events

Alerta De Seguridad para Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Covidien.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2015-09-02
  • Fecha de publicación del evento
    2015-09-02
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150902.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: covidien medi-trace cadence adult multi-function defibrillation electrodes the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning medi-trace cadence adult multi-function defibrillation electrodes (pre-connect), manufactured by covidien. the affected item numbers are 22550pc and 22770pc, with lot numbers 517521x, 519835x, 516313x, 519124x and 513426x. according to the alert, a recall was being conducted due to a low-level potential for damage to the wire insulation which was identified during a review of the manufacturing process. the use of products with this condition may result in a potentially increased risk for reduced or no patient therapy, arcing of current, sparking, and patient and/or clinician burns. according to the safety alert, no patient injuries have been reported related to this damaged wire insulation issues. users are advised to immediately quarantine and discontinue use of the affected devices. for details, please refer to the tga website:http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2015-rn-00803-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 september 2015.

Device

Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Covidien Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes
  • Manufacturer
    Covidien

Manufacturer

Covidien
  • 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
    DH