Events

Alerta De Seguridad O Notificaciones De Seguridad para HeartStart MRx defibrillator/monitor

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom 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
    Safety alert / Field Safety Notice
  • ID del evento
    MDA/2014/024
  • Número del evento
    CON428361
  • Fecha
    2014-06-26
  • Fecha de publicación del evento
    2014-06-26
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON428361?tabName=allTabs
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notas adicionales en la data
  • Causa
    Risk of delay in delivering cpr. when the heartstart mrx is used with the q-cpr meter in defibrillation mode, the meter may incorrectly display the ‘do not touch the patient’ icon. consequently, the user might not resume chest compressions in a timely manner, which could affect patient outcome. this problem can occur in aed or manual modes. philips issued a field safety notice dated april 2014 (reference fsn86100128a). when the heartstart mrx is in aed mode, the q-cpr meter is designed to display the ‘do not touch the patient’ icon during the shock advisory analysis period. if the user continues to deliver chest compressions when the shock advisory analysis begins, the ‘do not touch the patient’ icon may incorrectly remain on the screen after analysis or shock delivery is complete. when the heartstart mrx is in manual mode, the q-cpr meter is designed to display the ‘do not touch the patient’ icon when the device is charging to the selected energy. if the clinician continues to provide chest compressions while the device is charging, the q-cpr meter ‘do not touch the patient’ icon may incorrectly remain on the screen after shock delivery is complete. note: the mrx shock advisory decision and shock delivery continue to be executed correctly in all modes in aed mode the mrx continues to re-analyze for the shock advisory decision every two minutes with the exception of cpr meter feedback, all other mrx voice prompts including ‘resume cpr’ and ‘pause, analyzing’ operate as intended.
  • Acción
    Identify any affected devices in your possession, using the Field Safety Notice. You can continue to use your HeartStart MRx without the Q-CPR meter attached. If you use the HeartStart MRx with the Q-CPR meter attached and the Q-CPR meter displays the ‘Do Not Touch the Patient’ icon at an unexpected time, follow the MRx instructions for use and remove the meter from the patient and continue CPR according to local protocol. Philips will contact you to arrange to install the software upgrade.

Device

HeartStart MRx defibrillator/monitor
  • Modelo / Serial
  • Descripción del producto
    HeartStart MRx defibrillator/monitor. Model numbers M3535A and M3536A with Q-CPR™ meter option B08. Specific serial numbers affected. Affected MRx units have to meet all of the three criteria below: serial numbers from US00100153 to US00571587 inclusive the Q-CPR Meter Option B08 installed Software revision F.xx, R.xx, T.00.00 or T.00.01 installed
  • Manufacturer
    Philips

Manufacturer

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