Events

Alerta De Seguridad para BodyGuard 323 Infusion Pump

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

¿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
    2015-02-17
  • Fecha de publicación del evento
    2015-02-17
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150217.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: caesarea medical electronics bodyguard 323 infusion pump health canada posted a medical device safety alert concerning bodyguard 323 infusion pump [serial number: 69370, 71309, 71329, 71462], manufactured by caesarea medical electronics ltd. the manufacturer has identified a software issue with the bodyguard 323 that results in an over-infusion of medication without alarm. for the over-infusion to occur, specific set-up conditions must exist at the same time. serious injuries and/or deaths could occur due to the failure mode associated with this recall. for details, please refer to the following health canada website: http://healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2015/43737r-eng.Php if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 17 february 2015.

Device

BodyGuard 323 Infusion Pump
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Caesarea Medical Electronics BodyGuard 323 Infusion Pump
  • Manufacturer
    Caesarea Medical Electronics Ltd

Manufacturer

Caesarea Medical Electronics Ltd