BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RICHMAR

    MDR report key: 10438815 · Received August 21, 2020

    Report

    Report Number
    3012316249-2020-00025
    Event Type
    Malfunction
    Date Received
    August 21, 2020
    Date of Event
    July 29, 2020
    Report Date
    July 30, 2020
    Manufacturer
    COMPASS HEALTH BRANDS
    Product Code
    IRQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE END-USER USES THE HYDRA-THERM ALL DAY EVERYDAY AND YESTERDAY AS WE WERE CLOSING UP THE BACK OF IT WHERE THE POWER CONNECTS TO THE MACHINE BURST INTO FLAMES. IT MELTED THE POWER CORD, AND BURNED UP THE WALL. CLAIMS AGENT FOR CHB TALKED TO THE OWNER, THE CORD WAS SWAPPED OUT A FEW MONTHS AGO AND REPLACED IT DUE TO THE CORD SMOKING, THIS WAS 2-3 MONTHS AGO. THE END-USER PROVIDED PICTURES OF THE POWER CORD, A BLACK POWER CORD. CHB/RICHMAR POWER CORDS ARE GRAY IN COLOR WITH A CLEAR BLUEISH TINT TO THE PLUG ENDS. PAGE 3 OF THE INSTRUCTION MANUAL STATES THE WARRANTY FOR THE DEVICE IS FOR ONE (1) YEAR FROM THE DATE OF ORIGINAL END-USER PURCHASE. IT ALSO STATES "ALL REPAIRS TO THE PRODUCT MUST BE PERFORMED BY RICHMAR OR A RICHMAR AUTHORIZED SERVICE CENTER. ANY MODIFICATIONS OR REPAIRS PERFORMED BY UNAUTHORIZED CENTERS OR GROUPS WILL VOID THIS WARRANTY." ON PAGE 5, FIRST BULLETIN ON RIGHT SIDE, IT STATES "ALWAYS USE FACTORY AUTHORIZED REPLACEMENT PARTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901965 RICHMAR HYDRATHERM DELUXE IRQ COMPASS HEALTH BRANDS HT-R12-D

    Patients

    Seq Age Sex Outcome Treatment
    1