BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RICHMAR

    MDR report key: 12182363 · Received July 16, 2021

    Report

    Report Number
    3012316249-2021-00023
    Event Type
    Malfunction
    Date Received
    July 16, 2021
    Report Date
    July 16, 2021
    Manufacturer
    COMPASS HEALTH BRANDS
    Product Code
    IRQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HEATING ELEMENT WAS REPLACED 6 WEEKS AGO AND HAVE WORKED FINE SINCE THEN. LAST NIGHT SOMEONE WAS WALKING BY THE AREA AND SMELLED PLASTIC. THE UNIT WAS REPORTEDLY ON FIRE, A FIRE EXTINGUISHER WAS USED, THE ONSITE BIOMED DID A QUICK EVALUATION AND BELIEVES THAT THE FIRE STARTED FROM THE RECENTLY REPLACED HEATING ELEMENT. CONNECTORS TO THE HEATER ARE STILL GOOD. IT DEFINITELY APPEARS THAT THE HEATER (OR WIRES) SHORTED, NOT THE POWER SUPPLY. FUSE DID NOT BLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1079503 RICHMAR HYDRATHERM DELUXE IRQ COMPASS HEALTH BRANDS HT-R12-D

    Patients

    Seq Age Sex Outcome Treatment
    1