Events

Alerta De Seguridad para HAMILTON-T1 Ventilator

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
    2013-01-04
  • Fecha de publicación del evento
    2013-01-04
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130104a.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-t1 ventilator it has come to our attention that medical device manufacturer, hamilton medical ag, has initiated a field safety corrective action concerning hamilton-t1 ventilator with software version <= 1.1.2. according to the manufacturer, there is unexpected high internal oxygen consumption of hamil ton-t1 ventilators during ventilation of small pediatric patients. the current labeling does not include sufficient information about the internal oxygen consumption of the ventilators. depending on the ventilator setting and the patient's lung impedance, the internal gas consumption of the hamilton-t1 may be higher than expected. the internal oxygen consumption has to be taken into account in addition to the oxygen requirements for the patient's ventilation, especially when oxygen is limited. if the available oxygen supply during transport is depleted, the life of the patient may be endangered. furthermore, the manufacturer will rework and provide updated hamilton-t1 labeling (e.G., operator's manual), and develop and provide updated software with optimized internal oxygen consumption and overall oxygen consumption monitoring. it also advises users to calculate the required oxygen capacity prior to transports. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 04 january 2013.

Device

HAMILTON-T1 Ventilator

Manufacturer

Hamilton Medical AG