BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPASS HEALTH BRANDS

    MDR report key: 17037045 · Received June 1, 2023

    Report

    Report Number
    3012316249-2023-00014
    Event Type
    Injury
    Date Received
    June 1, 2023
    Report Date
    June 13, 2023
    Manufacturer
    SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.
    Product Code
    GYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DEVICE WAS RETURNED FOR INSPECTION, REPORT ATTACHED. FINDINGS ARE AS FOLLOWS: THE REPORTED PROBLEM COULD NOT BE VERIFIED, THE DEVICE WAS TESTED AND PASSED ALL FUNCTIONAL TESTS WITH NO PROBLEMS FOUND, NO ACCESSORIES WERE RECEIVED SO THEY COULD NOT BE TESTED. DEVICE WAS TESTED ON ALL STIM TREATMENTS FOR SEVERAL HOURS WITH NO PROBLEMS.

    Description of Event or Problem · 0

    THE PT USED THIS AT THE CLINIC AND THEY HAVE HAD IT 2 YEARS. THEY WERE USING 4 DURA STICK PLUS 2" SQUARES ON CLEAN SKIN SURROUNDING THE KNEE MORE THEN 4 INCHES APART. THE ELECRTRODES HAD BEEN USED 2 OR 3 TIME PRIOR TO INJURY. THE DEVICE WAS SHUT OFF BEFORE THE ELECTRODES WERE REMOVED OR ADJUSTED. THEY WERE USING IFC 4 POLE CONTINUOUS AND NO BURN MARKS SHOW UP UNTIL LATER. THEY HAVE NOT FULLY HEALED YET. THE PATIENT DID SEEK MEDICAL ATTENTION THERE WERE 4 ELECTRODES USED ABOVE AND BELOW THE KNEE JOINT, MEDIALLY, AND LATERALLY (BRACKETING THE KNEE JOINT) IN AN X PATTERN WITH THE 2 CHANNELS. THE ICE PACK WAS PLACED ON TOP OF THE KNEE JOINT, WHICH DID COVER THE ELECTRODES. WE USE THIS SET-UP ALL THE TIME WITH OUR PATIENTS WITHOUT A PROBLEM. WE USED THIS SAME MACHINE ON A DIFFERENT PATIENT AND THERE WAS A BURNING SMELL COMING OUT OF THE MACHINE, SO WE DIDN'T COMPLETE THE SET UP AND PUT THE UNIT OUT OF SERVICE. TRIGGER WORD FORM INFORMATION: THE PATIENT WAS A 76 YEAR OLD MALE WITH NO PRE-EXISTING CONDITIONS. AN ICE PACK WAS USED AT THE TIME OF EVENT. BURN MARKS SHOWED UP LATER. WAS USED ON IFC - CONTINUOUS, NO MODULATING. THEY ARE UNSURE IF LEADS/CABLES HAVE BEEN REPLACED WITHIN 6 MONTHS. THEY ARE USING 2" SQUARE SELF ADHESIVE ELECTRODES SURROUNDING KNEE - 4" DISTANCE, 4 IN TOTAL. USED 2-3 TIMES PRIOR TO INJURY. NOTHING WAS APPLIED TO THE SKIN PRIOR AND THE DEVICE WAS TURNED OFF WHEN PADS WERE REMOVED/ADJUSTED. SKIN WAS CLEAR. BURNS APPEARED SEVERAL DAYS LATER. THEY ARE ONGOING, NOT FULLY HEALED. PATIENT DID SEEK MEDICAL ATTENTION. ELECTRODES ARE NOT SHARED BETWEEN PATIENTS. THEY ARE STORED IN A CONTAINER PACKAGED IN ORIGINAL PACKAGE. PATIENT IS ALLERGIC TO SULFA DRUGS. PULSE RATE WAS 80-150 HZ. THEY WERE NOT USING THE ELECTRODES SUPPLIED WITH THE DEVICE, THEY ARE USING 2" SQUARE DURA STICK PLUS ELECTRODES. THEY ARE "UNSURE - CHANGED OUT IN THE PAST" WHEN ASKED IF THEY HAVE TRIED NEW LEAD WIRES. THEY STATE "NO - LEAD WIRES WERE INTACT" WHEN ASKED IF ANY SIGN OF DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1837164 COMPASS HEALTH BRANDS THERATOUCH EX4 GYB SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. DQ7200

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention