Events

Alerta De Seguridad para BeneHeart D1 Defibrillator/ Monitor

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

¿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
    2014-11-18
  • Fecha de publicación del evento
    2014-11-18
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141118b.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: beneheart d1 defibrillator/ monitor the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning beneheart d1 defibrillator/ monitor, manufactured by mindray. the affected product is beneheart d1 with the first four digits of the serial number as fq37/ fq38/ fq39/ fq3a/ fq3b/ fq3c/ fq41/ fq42/ fq43/ fq44/ fq45/ fq46/ fq47. the manufacturer has identified the affected aeds might fail to boot. when this issue occurs, the status indicator of the aed is off. the reason for the startup failure of the aed is due to abnormal reset of the power management circuit on the main control board. the manufacturer advises affected users to discontinue use of the aed. the manufacturer will repair the affected aeds as soon as possible. for details, please refer to the following link: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con473632 according to the manufacturer, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 18 november 2014.

Device

BeneHeart D1 Defibrillator/ Monitor
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: BeneHeart D1 Defibrillator/ Monitor
  • Manufacturer
    Mindray

Manufacturer

Mindray