BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RICHMAR

    MDR report key: 10447848 · Received August 25, 2020

    Report

    Report Number
    3012316249-2020-00026
    Event Type
    Malfunction
    Date Received
    August 25, 2020
    Report Date
    August 25, 2020
    Manufacturer
    COMPASS HEALTH BRANDS
    Product Code
    IMI
    PMA / PMN Number
    K032941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE END-USERS AUTOSOUND HEAD IS SHORTING OUT ON THEIR UNIT. IT SOUNDS LIKE IT IS MAKING AN ELECTRICAL CLICKING NOISE. IT ALSO LOOKS LIKE THE WIRES HAVE FRAYED OR BEEN CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914286 RICHMAR AUTOSOUND APPLICATOR IMI COMPASS HEALTH BRANDS 400-001

    Patients

    Seq Age Sex Outcome Treatment
    1