Events

Alerta De Seguridad para Integra Camino Intracranial Pressure (ICP) Monitor and the Integra Licox PtO2 and Temperature Monitor

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

¿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
    2016-01-12
  • Fecha de publicación del evento
    2016-01-12
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160112.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: integra camino intracranial pressure (icp) monitor and the integra licox pto2 and temperature monitor the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning integra camino intracranial pressure (icp) monitor (catalogue number: cam02; serial number: all) and the integra licox pto2 and temperature monitor (catalogue number lcx02; serial number: all ) manufactured by integra lifesciences (ireland) ltd. according to the alert, the speakers in camino icp monitors (cam02) and the licox pto2 and temperature monitors (lcx02) may potentially malfunction. if this occurs, the monitors will stop providing an audible tone at start-up or at alarm points during use. although unlikely, this may lead to central herniation that could potentially result in brain death or reversible ischemia; moderate hypoxic brain injury; elevation of icp or decrease in pto2. no reports of patient injury or adverse events have been received. the affected units are to be returned to the manufacturer for a software upgrade to lower the input signal supplied to the speaker assembly. the monitor case will also be modified to increase the decibel level. for details, please refer to the tga website:http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2016-rn-00030-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 12 january 2016.

Device

Integra Camino Intracranial Pressure (ICP) Monitor and the Integra Licox PtO2 and Temperature Mon...
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Integra Camino Intracranial Pressure (ICP) Monitor and the Integra Licox PtO2 and Temperature Monitor
  • Manufacturer
    Integra Lifesciences

Manufacturer

Integra Lifesciences