Events

Alerta De Seguridad para HeartStart XL+ (861290) Defibrillator/Monitor

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

¿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
    2012-03-23
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120323.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
    Field safety notice: philips heartstart xl+ (861290) defibrillator/monitor medical device manufacturer, philips healthcare, has issued a customer information letter concerning heartstart xl+ (861290) defibrillator/monitor. internal testing showed that when using the device in aed in the following sequence: an alarm condition (e.G. v-fib, v-tach, asystole) occurs the therapy dial is changed from aed mode to any other clinical mode or alarms are enabled in aed mode then any subsequent ecg alarms may not be visible or audible. philips has released a new version of software (a.01.00) that changes the alarm behavior. to mitigate the issue, philips recommends that clinical judgment should be used and the patient’s conditions should be observed when selecting a different clinical mode after aed mode. as an alternative to clear the behavior, exit aed mode and select off, wait ten seconds before entering a different clinical mode. according to the local supplier, the affected devices were distributed to hong kong. the customer information letter will be sent to all affected customers. if you are in possession of the products, please contact your supplier for necessary actions.

Device

HeartStart XL+ (861290) Defibrillator/Monitor
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Philips HeartStart XL+ (861290) Defibrillator/Monitor
  • Manufacturer
    Philips Healthcare

Manufacturer

Philips Healthcare
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DH