Events

Alerta De Seguridad para micro-pace 4580

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

¿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
    2012-09-25
  • Fecha de publicación del evento
    2012-09-25
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120925a.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: pace medical micro-pace 4580 the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning micro-pace 4580, manufactured by pace medical, inc. pace medical has observed in the ref 4580 that in a specific use of the device the defibrillation protection circuitry may not function as well as intended. if the device is used on a patient, with heart wires and the patient’s heart is defibrillated directly on the heart, there may be a chance that the device will be damaged from the defibrillation output current. the manufacturer has designed and validated a new defibrillation protection circuit which will eliminate the potential for this to occur. furthermore, it advised that: users should return the affected device for a complimentary upgrade. the device should not be used in cardiac surgical theaters where heart wires are used and defibrillation is applied directly to the heart tissue. ref 4580 can be used in other procedures while scheduling product return, but patients should be monitored while the device is in use and a backup device should be on hand. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con185136 if you are in possession of the product, please contact your supplier for necessary actions. posted on 25 september 2012.

Device

micro-pace 4580
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Pace Medical MICRO-PACE 4580
  • Manufacturer
    Pace Medical

Manufacturer

Pace Medical