Events

Alerta De Seguridad para HeartStart MRx Monitor/Defibrillator

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

¿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
    2014-02-26
  • Fecha de publicación del evento
    2014-02-26
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140226.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: philips heartstart mrx monitor/defibrillator medical device manufacturer, philips healthcare, has issued a field safety notice (fsn) concerning heartstart mrx monitor/defibrillator. the affected model numbers are m3535a, m3536a, m3536j, m3536m, m3536m5, and m3536mc, and the affected serial numbers are within the range us00100100 - us00550668. the ecg trunk cable and connector block of the mrx could be susceptible to accelerated wear, which could result in an interrupted ecg signal. interruption of the ecg signal can cause loss of demand mode pacing, inability to perform synchronized cardioversion with paddles, and disruption of leads ecg monitoring, which could delay appropriate treatment. defibrillation, fixed mode pacing, ecg monitoring via pads/paddles, and other monitoring functions are not impacted by this issue. the manufacturer will provide a hardware upgrade on all affected units. users can continue to use mrx prior to receiving the hardware upgrade. if the above problem occurs, users should refer to the heartstart mrx instructions for use for troubleshooting assistance and follow the technical advice as listed in the fsn. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 26 february 2014.

Device

HeartStart MRx Monitor/Defibrillator
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Philips Medical Systems HeartStart MRx Monitor/Defibrillator
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DH