BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPER FLEX CARDIO

    MDR report key: 3994192 · Received July 25, 2014

    Report

    Report Number
    3994192
    Event Type
    Malfunction
    Date Received
    July 25, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 15, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHILIPS "FOOTBALL" NON INVASIVE BLOODPRESSURE MONITOR MALFUNCTIONED AND WOULD NOT OPERATE. EQUIPMENT PULLED FROM SERVICE AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436738 XPER FLEX CARDIO PHYSIOLOGICAL MONITORING SYSTEM MHX PHILIPS MEDICAL SYSTEMS FC2010 *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR NO OTHER THERAPIES