BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MX40 2.5 GHZ SMART HOPPING

    MDR report key: 4093062 · Received September 10, 2014

    Report

    Report Number
    1218950-2014-05451
    Event Type
    Malfunction
    Date Received
    September 10, 2014
    Report Date
    September 2, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K113125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS NO AUDIO FROM THEIR MX40 DEVICE. THERE WAS NO REPORT OF A DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559663 MX40 2.5 GHZ SMART HOPPING DETECTOR AND ALARM, ARRHYTHMIA DSI PHILIPS MEDICAL SYSTEMS 865351

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown