BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MX40 1.4 GHZ SMART HOPPING

    MDR report key: 3043459 · Received March 13, 2013

    Report

    Report Number
    1218950-2013-00812
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Report Date
    February 12, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K113125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THEY WERE NOT RECEIVING AUDIO FROM THEIR MX40 DEVICE. THERE WAS NO PT INVOLVEMENT. THE DEVICE WAS RETURNED TO PHILIPS BENCH REPAIR FOR EVAL. BENCH REPAIR FOUND THAT THE CASE WAS CRACKED, THE BATTERY CONTACTS WERE DAMAGED AND THE DEVICE DID NOT PROVIDE SOUND. THE DISPLAY, RADIO BOARD AND CASE COMPONENTS WERE REPLACED TO RESOLVE THE ISSUE. THE DEVICE PASSED ALL TEST AFTER THE REPAIR. THIS IS NOT A DEVICE MALFUNCTION. THE ISSUE IS CONSISTENT WITH ROUGH USE, OUTSIDE NORMAL AND EXPECTED (BAD BATTERY CONTACTS, CASE CRACKED, OR CORROSION). THE REPAIRED DEVICE WAS RETURNED TO THE CUSTOMER. TRENDING FOR THIS ISSUE SUPPORTS THAT THERE WAS NO MALFUNCTION OR HEALTH RISK AND THERE ARE NO DESIGN, MFG, MATERIALS, OR LABELING PROBLEMS. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY WERE NOT RECEIVING AUDIO FROM THEIR MX40 DEVICE. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106192 MX40 1.4 GHZ SMART HOPPING DSI PHILIPS MEDICAL SYSTEMS 865350

    Patients

    Seq Age Sex Outcome Treatment
    1