BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MX40 1.4 GMZ SMART HOPPING

    MDR report key: 3952263 · Received May 13, 2014

    Report

    Report Number
    1218950-2014-02679
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Report Date
    April 21, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K113125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 NO AUDIO FROM THE MX40. THERE IS NO REPORT OF PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285708 MX40 1.4 GMZ SMART HOPPING DSI PHILIPS MEDICAL SYSTEMS 865350

    Patients

    Seq Age Sex Outcome Treatment
    1