Events

Alerta De Seguridad para PROCARE B20 and B40 Monitors

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

¿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
    2012-11-06
  • Fecha de publicación del evento
    2012-11-06
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121106.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: ge procare b20 and b40 monitors the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning procare b20 and b40 monitors, manufactured by ge healthcare. according to the manufacturer, the ‘v tachy’ and ‘v fib’ alarms of monitor procare b20 or procare b40 are disabled in neonatal mode which could result in a missed lethal arrhythmia alarm and a potentially critical event. other modes and parameters are not affected. the issue affects monitor procare b20 or b40 devices with the software version vsp-a_1.10 (or earlier). the manufacturer advised clinician should stop using monitor in neonatal mode. they will provide a software solution to correct this issue. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con199544 if you are in possession of the product, please contact your supplier for necessary actions. posted on 6 november 2012.

Device

PROCARE B20 and B40 Monitors
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: GE PROCARE B20 and B40 Monitors
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare