BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS INTELVIUE MX 40 CENTRAL STATIONS AND TRANSMITTERS

    MDR report key: 3252401 · Received July 24, 2013

    Report

    Report Number
    MW5031077
    Event Type
    Malfunction
    Date Received
    July 24, 2013
    Date of Event
    July 7, 2013
    Report Date
    July 17, 2013
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WITH INTERMITTENT ATRIAL FIBRILLATION IN INPATIENT TELEMETRY SETTING WHERE PHILIPS INTELIVUE MX 40 MONITORING SYSTEM IS USED. DURING A PERIOD OF CONVERSION BACK INTO AFIB, THERE WERE INTERMITTENT PERIODS OVER A 20-MINUTE TIMESPAN IN WHICH THE WAVEFORMS WERE NOT VISIBLE, WITH INABILITY TO RECORD/STORE WAVEFORMS. THIS HAS BEEN AN ONGOING ISSUE SINCE AN UPGRADE TO THE INTELIVUE CENTRAL STATIONS AND TRANSMITTERS 3 MONTHS AGO. IT HAS BEEN REPORTED ON VARIOUS OCCASIONS TO PHILIPS, WHO STATE THIS IS AN ONSITE ISSUE THAT OUR FACILITY NEEDS TO RESOLVE. OTHER INPATIENTS ON THE TELEMETRY SYSTEM HAVE HAD INTERMITTENT MONITORING FAILURE AS WELL DURING THESE EPISODES. POTENTIAL FOR ADVERSE OUTCOMES OF CONCERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345100 PHILIPS INTELVIUE MX 40 CENTRAL STATIONS AND TRANSMITTERS NONE MHX PHILIPS HEALTHCARE MX 40

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR