BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MX40 1.4 GHZ SMART HOPPING

    MDR report key: 3222145 · Received July 2, 2013

    Report

    Report Number
    1218950-2013-02765
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 6, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K113125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO PHILIPS FOR EVALUATION. A VISUAL INSPECTION OF THE DEVICE NOTED CORRODED BATTERY CONTACTS AND A CRACKED CASE. THE FAILURE WAS REPLICATED WHERE THERE WAS NO SOUND AND THE SPEAKER WAS DEFECTIVE. THE CUSTOMER RECEIVED AN EXCHANGE MX40 DEVICE. TRENDING FOR THIS ISSUE SUPPORTS THAT THERE WAS NO HEALTH RISK AND THERE ARE NO DESIGN, MANUFACTURING, MATERIALS, OR LABELING PROBLEMS. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NO AUDIO FROM THEIR MX40 DEVICE. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300621 MX40 1.4 GHZ SMART HOPPING DSI PHILIPS MEDICAL SYSTEMS 865350

    Patients

    Seq Age Sex Outcome Treatment
    1