Alerta De Seguridad para cardioLife defibrillator, TEC-5521K and TEC-5531K

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

¿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
    2012-11-14
  • Fecha de publicación del evento
    2012-11-14
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • 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: nihon kohden cardiolife defibrillator, tec-5521k and tec-5531k the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning a potential malfunction of cardiolife defibrillator (model tec-5521k and tec-5531k) using a software version ≦ 01-20, manufactured by nihon kohden corporation. during operation the defibrillator in battery mode there are several battery alarms when reaching critical levels of the battery capacity. when the battery alarms are ignored and the battery is discharged continuously, the defibrillator shut down automatically. in rare cases this could lead to a damage of the power control circuit and the defibrillator could not turn on either in battery mode nor in ac power mode again. this defect requires maintenance of the defibrillator by the authorized service partner. the frequency of the reported incidences caused by this malfunction is approx. 0.017%. the manufacturer advised users to make sure that the battery of the defibrillator is charged completely always and that the battery test and the exchange of the battery is performed regularly according the instructions in the operator’s manual and follow the instructions related to the battery alarms. this avoids the automatically shut-down of the defibrillator. also, the manufacturer will eliminate this potential malfunction to the affected defibrillators by the installation of a software upgrade with an improved algorithm for the automatically shut-down of the defibrillator when the battery is discharged completely. this software upgrade will be installed by the manufacturer during the next regularly maintenance. for details, please refer to the mrha website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con203860 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 14 november 2012.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Nihon Kohden cardioLife defibrillator, TEC-5521K and TEC-5531K
  • Manufacturer

Manufacturer