Events

Notificaciones De Seguridad De Campo acerca de HeartStart MRx

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Philips.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    Philips has determined that there is a possibility of abnormal operation of the heartstart mrx monitor / defibrillator. in extremely rare cases, the following operating patterns may occur on the device: 1. if the pins with which the battery is attached to the device are damaged or dirty, the electrical connection may be poor. when the device is powered only by a battery, the device may not turn on or restart; 2. when the heartstart mrx monitor / defibrillator is disconnected from the power supply and a single battery is used as the sole power source, the following patterns of abnormal device operation may occur: a. when the user presses the charge button, the device attempts to charge, and after about 20 seconds, displays a "shock equipment malfunction" error message and is unable to perform shock treatment; b. the promotion may be interrupted without warning. these device performance patterns may occur until the unit is reset. both of these problems can cause a delay in monitoring or treatment.

Device

HeartStart MRx

Manufacturer

Philips
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    AMPMDRS