Events

Alerta De Seguridad para Commander FLEX UK power supply

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

¿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
    2014-04-29
  • Fecha de publicación del evento
    2014-04-29
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140429.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: cardiocom commander flex uk power supply the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning cardiocom commander flex, manufactured by cardiocom llc. the affected model is cd310. the manufacturer has received one complaint of a power supply adaptor breaking apart while in a patient’s use. this power supply adaptor is purchased by the manufacturer and used with the cardiocom commander flex in the united kingdom (uk). all commander flex devices that are distributed in the uk are affected by this recall; these include serial numbers 1000400200 through 1000400264. according to the manufacturer, there are a potential for serious injury or death in this defect. when the adaptor is damaged, a portion of the plugin remains in the wall socket. this broken adaptor presents a serious risk of electrical shock that could prove fatal. the manufacturer is advising users not to touch the affected products or otherwise come into contact with the adaptor if breakage occurs and also not to unplug the adapter, or to plug it in if the user had not already inserted it into the wall socket. the manufacturer will exchange the defective adaptor and replace an adaptor that does not have the same risk of damage to customers. once the exchange has been completed, users may resume the use of the commander flex as they normally would, pursuant to the instructions for use for the medical device. for details, please refer to mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con406390 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 29 april 2014.

Device

Commander FLEX UK power supply
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Cardiocom Commander FLEX UK power supply
  • Manufacturer
    Cardiocom LLC

Manufacturer

Cardiocom LLC
  • 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