Events

Alerta De Seguridad para Samaritan PDU 400

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por HeartSine Technologies 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
    2013-10-16
  • Fecha de publicación del evento
    2013-10-16
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131016b.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: heartsine samaritan pdu 400 the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning samaritan pdu 400, manufactured by heartsine technologies ltd. the affected serial numbers are from 08p00001003 to 11p00007347. the software of samaritan pdu 400 device may fail to accurately determine the remaining capacity of the device battery. rather than emitting an alarm warning users that the device has insufficient battery to deliver therapy, the device may simply shut down. the affected device may be unable to operate during a sudden cardiac arrest. the manufacturer will arrange replacement of the affected pdu 400 devices for users. according to the regional distributor in singapore, the affected products were not distributed in hong kong. for details, please refer to mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con321967 if you are in possession of the product, please contact your supplier for necessary actions. posted on 16 october 2013.

Device

Samaritan PDU 400
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: HeartSine Samaritan PDU 400
  • Manufacturer
    HeartSine Technologies Ltd

Manufacturer

HeartSine Technologies Ltd
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DH