Events

Alerta De Seguridad para heartstart mrx monitor/defibrillators

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
    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_20140226b.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/defibrillators medical device manufacturer, philips healthcare, has issued a field safety notice concerning heartstart mrx monitor/defibrillator. the affected model numbers and serial numbers are as follows: model m3535a: us00100100 to us00541372 model m3536a: us00100902 to us00541375 model m3536j: us00209838 to us00332675 model m3536mc: us00500001 to us00500020 according to the manufacturer, a component of the mrx processor board may be susceptible to damage from electrostatic discharge. damage to these components can disrupt electrocardiography (ecg) and pulse oximetry (spo2) functionality leading to an inability to perform: demand mode pacing 12 lead ecg acquisition and analysis ecg monitoring via leads pulse oximetry (spo2) the presence of this condition will be displayed on the ready for use indicator as a solid red x with periodic audio chirp. a hardware upgrade will be provided to correct the issue. the manufacturer advises healthcare professionals that the affected product can continue to be used prior to receiving the hardware update. the manufacturer also provides instruction for the appropriate actions to be taken if the affected product displays a solid red ‘x’. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 26 february 2014.

Device

heartstart mrx monitor/defibrillators
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Philips HeartStart MRx Monitor/Defibrillators
  • Manufacturer
    Philips Healthcare

Manufacturer

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