Events

Alerta De Seguridad para IntelliCuff Standalone

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
    2017-06-12
  • Fecha de publicación del evento
    2017-06-12
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170612.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 intellicuff standalone medical device manufacturer, hamilton medical ag, has issued a medical device safety alert concerning its intellicuff standalone. the model number involved is pn 951001 and the affected serial numbers are from 1000 to 2090. the manufacturer’s analysis of a customer complaint has identified an issue relating to the performance of the motor in the intellicuff standalone device. during use, the motor may cease to function. the alarm sounds and the red leds blink in all segments. the intellicuff standalone must be switched off to silence the alarm. the number of failures is unacceptably high causing nuisance alarms and customer complaints. according to the manufacturer’s assessment, there is no risk for the patient or user related to this failure. product recall and replacement is on-going. the manufacturer will provide the necessary hardware improvements for intellicuff standalone devices. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 12 june 2017.

Device

IntelliCuff Standalone
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Hamilton Medical AG IntelliCuff Standalone
  • Manufacturer
    Hamilton Medical AG

Manufacturer

Hamilton Medical AG