BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MX40 1.4 GHZ SMART HOPPING

    MDR report key: 3043461 · Received March 13, 2013

    Report

    Report Number
    1218950-2013-00811
    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
    MO, 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 FOR EVAL. THE EVAL FOUND THAT THE CASE WAS CRACKED, THE TOUCHSCREEN WAS SCRATCHED AND THE DEVICE WOULD NOT TURN ON. SINCE THE DEVICE WOULD NOT TURN ON, THERE WAS NO AUDIO. THE SYSTEM BOARD WAS REPLACED TO RESOLVE THE ISSUE. THE ISSUE IS MOST CONSISTENT WITH USER HANDING WHERE THE CASE IS CRACKED AND THE DEVICE NO LONGER TURNS ON. THIS IS NOT A DEVICE MALFUNCTION. 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
    106345 MX40 1.4 GHZ SMART HOPPING DSI PHILIPS MEDICAL SYSTEMS 865350

    Patients

    Seq Age Sex Outcome Treatment
    1