BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MX40 1.4 GHZ SMART HOPPING

    MDR report key: 8687472 · Received June 11, 2019

    Report

    Report Number
    1218950-2019-04129
    Event Type
    Malfunction
    Date Received
    June 11, 2019
    Report Date
    May 29, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    UDI-DI
    00884838082236
    PMA / PMN Number
    K113125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SPEAKER MALFUNCTION NOP ERROR MESSAGE. NO THERE WAS NO ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479397 MX40 1.4 GHZ SMART HOPPING MX40 1.4 GHZ SMART HOPPING DSI PHILIPS MEDICAL SYSTEMS 865350 00884838082236

    Patients

    Seq Age Sex Outcome Treatment
    1