BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MX40 2.4 GHZ SMART HOPPING

    MDR report key: 4161718 · Received July 23, 2014

    Report

    Report Number
    1218950-2014-04250
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Report Date
    July 1, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K113125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INTERNAL SPEAKER WAS NOT WORKING IN THE MX40. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429979 MX40 2.4 GHZ SMART HOPPING DSI DSI PHILIPS MEDICAL SYSTEMS 865351

    Patients

    Seq Age Sex Outcome Treatment
    1