BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MX40 1.4 HGZ SMART HOPPING

    MDR report key: 3772884 · Received January 9, 2014

    Report

    Report Number
    1218950-2013-06819
    Event Type
    Malfunction
    Date Received
    January 9, 2014
    Report Date
    December 10, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K113125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT NO AUDIO WAS BEING EMITTED FROM THE MX40. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16454 MX40 1.4 HGZ SMART HOPPING DSI PHILIPS MEDICAL SYSTEMS 865350

    Patients

    Seq Age Sex Outcome Treatment
    1