BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RICHMAR

    MDR report key: 11648064 · Received April 12, 2021

    Report

    Report Number
    3012316249-2021-00016
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Report Date
    April 21, 2021
    Manufacturer
    COMPASS HEALTH BRANDS
    Product Code
    IMG
    PMA / PMN Number
    K032941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DEVICE RETURNED FOR INSPECTION: COMPLAINT CONFIRMED. THE FISCHER CONNECTOR WAS DAMAGED. THE FISCHER CONNECTOR WAS REPAIRED THEN THE APPLICATOR WAS TESTED AND PASSED. NO PARTS WERE NEEDED FOR REPAIRS. THE OUTER SHELL OF THE FISCHER CONNECTOR WAS AROUND THE WIRES WHEN WE GOT IT SO THEY WERE NOT VISIBLE AT FIRST BUT WHEN THE FISCHER CONNECTOR CASE WAS OPENED THE RED WIRE WAS PULLED OUT OF THE PINS SO THE END OF THE WIRE WAS VISIBLE.

    Description of Event or Problem · 1

    THE PLUG WAS PULLED OUT OF THE UNIT AND THE CONNECTOR BROKE OFF. THE CUSTOMER REPORTED THERE MAY BE ONE WIRE THAT IS SHOWING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545759 RICHMAR APPLICATOR AUTOSOUND IMG COMPASS HEALTH BRANDS 410-200

    Patients

    Seq Age Sex Outcome Treatment
    1