Events

Alerta De Seguridad para Hamilton-C2 (PN 160001) and Hamilton-C3 (PN 160005) Ventilator Unit

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

¿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
    2017-09-05
  • Fecha de publicación del evento
    2017-09-05
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170905.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: hamilton medical ag hamilton-c2 (pn 160001) and hamilton-c3 (pn 160005) ventilator unit the medicines and healthcare products regulatory agency (mhra) of the united kingdom (uk) has issued a medical device safety alert concerning hamilton-c2 (pn 160001) and hamilton-c3 (pn 160005) ventilator unit, manufactured by hamilton medical ag. the analysis of a customer complaint has identified an issue relating to the battery charge of the hamilton-c2/c3 batteries after a usage of two and a half years. the battery fuel gauge may indicate a higher battery charge as to what is available. the technical failure 444001"low battery" high priority alarms are triggered, alerting the operator both acoustically and visually before entering ambient mode. according to the manufacturer, when batteries are depleted, the operator is alerted by high priority alarms and if the ventilator is not immediately connected to an ac power outlet, the ventilator will switch into ambient mode. the alarm is triggered in every case to alert medical staff. the affected users are instructed to take the following actions:- the operator should make themselves familiar with the batteries' manufacturing date and react in time if battery is more than two years old. any battery with a manufacturing date to two years prior to the current date should be replaced. if the battery is less than two years old, return battery to slot, pushing until clip clicks into place, locking in the battery. use a screwdriver to lock metal clip back into place over battery. close battery door. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notice-29-august-to-1-september-2017 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 5 september 2017.

Device

Hamilton-C2 (PN 160001) and Hamilton-C3 (PN 160005) Ventilator Unit
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Hamilton Medical AG Hamilton-C2 (PN 160001) and Hamilton-C3 (PN 160005) Ventilator Unit
  • Manufacturer
    Hamilton Medical AG

Manufacturer

Hamilton Medical AG