BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RICHMAR

    MDR report key: 12024816 · Received June 18, 2021

    Report

    Report Number
    3012316249-2021-00020
    Event Type
    Malfunction
    Date Received
    June 18, 2021
    Report Date
    August 16, 2021
    Manufacturer
    COMPASS HEALTH BRANDS
    Product Code
    IRQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DEVICE WAS RETURNED FOR INSPECTION. THE RESULTS ARE AS FOLLOWS: INVESTIGATION AND EVALUATION: THE SERIAL NUMBER OF THE COMPLAINT DEVICE DOCUMENTS THAT THE DEVICE WAS NOT BUILT BY SDP. THE HEATING ELEMENT DID NOT HEAT UP WHEN THE DEVICE WAS IN THE DRAIN MODE. THE HEATING ELEMENT DID NOT HEAT UP WHEN THE TUB WAS EMPTY, AND THE DEVICE WAS IN THE HEAT MODE. THE DEVICE PASSED ALL TESTING. EVALUATION OF THE DEVICE SHOWS THE COMPLAINT COULD NOT BE VERIFIED. USER MANUAL ATTACHED. PAGE 10, CLEANING INSTRUCTIONS, CAUTION: ALWAYS UNPLUG THE UNIT FROM THE ELECTRICAL OUTLET WHEN CLEANING THE UNIT.

    Description of Event or Problem · 1

    THE HEATING ELEMENT ON THEIR UNIT TURNED RED HOT, GLOWING RED, IGNITED A PAPER TOWEL THAT WAS BEING USED FOR CLEANING WHILE IN DRAIN MODE. THE CUSTOMER CURRENTLY HAS THE UNIT TURNED ON AND IT IS RUNNING NORMALLY WITH WATER IN IT BUT THE MAIN CONCERN IS THAT 1. IT WAS HEATING WITH NO WATER IN THE UNIT, 2. THE UNIT WAS HEATING WHILE IN DRAIN MODE. THE CUSTOMER HAS RETESTED THE UNIT AND HAS NOT BEEN ABLE TO DUPLICATE IT. THIS INCIDENT ONLY HAPPENED WHEN STAFF WAS CLEANING/DRAINING. WHEN WATER WAS DRAINED, STAFF WENT TO CLEAN THE SEDIMENT ON THE BOTTOM WITH A PAPER TOWEL AND IT WAS REPORTED THE PAPER IGNITED AND ELEMENT WAS GLOWING RED. I HAVE PERFORMED SEVERAL TESTS IN DRAIN MODE AND IN HEAT MODE AND HAVE NOT BEEN ABLE TO DUPLICATE THE ISSUE. I DID TEST DRAINING AND WITH NO WATER, TURN TO HEAT MODE, AND UNIT DID NOT HEAT UP OR GLOW. I DID FILL WITH WATER AND HEAT WATER TO SET TEMPERATURE AND NO ISSUES. I DID OHM OUT THE HEATING ELEMENT AND THE HIGH LIMIT SWITCH. THEY BOTH CHECK OUT FINE. NO INJURY WAS REPORTED. THE PAPER TOWELS WERE DRY BUT THE BOTTOM OF THE TANK BY DRAIN WAS NOT COMPLETELY DRY, AS THERE IS ALWAYS A BIT OF WATER WITH THE SEDIMENT LEFT OVER WHICH IS WHY WE USE PAPER TOWELS TO WIPE IT OUT. YES IT WAS IN DRAIN MODE NOT IN HEAT MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919775 RICHMAR HYDRATHERM DLX IRQ COMPASS HEALTH BRANDS HT-PAT-D120

    Patients

    Seq Age Sex Outcome Treatment
    1