Events

Alerta De Seguridad para Samaritan PAD 500P Automated External Defibrillators

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

¿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
    2014-03-04
  • Fecha de publicación del evento
    2014-03-04
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140304a.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 pad 500p automated external defibrillators the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning samaritan pad 500p automated external defibrillators, manufactured by heartsine technologies, inc. the affected serial numbers ranged from 10b0010001 to 14b00461703, manufactured between february 2010 and january 2014. according to the manufacturer, the software in the concerned defibrillators may miscalculate the cpr rate of compression per minute being administered to the patient. the rescuer may, therefore, be incorrectly advised by the device to “push slower” when, in fact, the cpr rate is at an acceptable level. to address the issue, the manufacturer has posted an updated version of the software for the samaritan pad 500p on the heartsine technologies website for download. for details, please refer to the following link:http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con382708 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 04 march 2014.

Device

Samaritan PAD 500P Automated External Defibrillators
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: HeartSine Samaritan PAD 500P Automated External Defibrillators
  • Manufacturer
    HeartSine Technologies

Manufacturer

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