BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPASS HEALTH BRANDS

    MDR report key: 12106444 · Received July 2, 2021

    Report

    Report Number
    3005170249-2021-00001
    Event Type
    Injury
    Date Received
    July 2, 2021
    Report Date
    June 4, 2021
    Manufacturer
    SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.
    Product Code
    GZJ
    PMA / PMN Number
    K150436
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ASKED FOR FURTHER INFORMATION FOR ANALYSIS FOR TWICE, BUT NO INFORMATION WAS OBTAINED.

    Description of Event or Problem · 1

    CUSTOMER STATES UNIT CAUSED A BURN ON A RESIDENTS LOWER BACK. CUSTOMER WANTED TO MAKE NOTE THAT AT THE TIME OF THE INCIDENT, THE MACHINE TURNED ITSELF OFF AND SHOWED AN ERROR MESSAGE. LOOKING AT THE MANUAL, I BELIEVE IT WAS THE ERROR, "THE OUTPUT CURRENT EXCEEDS THE SETTING CURRENT VALUE." I HAD NOT SEEN THIS ERROR CODE BEFORE. AFTER SEEING THIS MESSAGE, THE DEVICE WAS RESTARTED AND THE TREATMENT WAS CONTINUED FOR 8 MORE MINUTES AT 53V. WHEN THE ELECTRODE PADS WERE REMOVED, THERE WAS NO EVIDENCE OF ABNORMALITY ON THE SKIN. THE ELECTRODES USED WERE VALUTRODE, REF #CF5050. THEY ALSO WANTED TO EMPHASIZE THAT THE PACK WAS NEW FOR THAT TREATMENT. THE MACHINE WAS OPERATED BY A PHYSICAL THERAPIST. RELEVANT MEDICAL CONDITIONS: S/P CERVICAL AND LUMBAR LAMINECTOMIES W/ HISTORY OF SEVER STENOSIS C2-C5. THE BURNS ARE DESCRIBED AS '4 FULL-THICKNESS BURNS UNDER PLACEMENT OF ELECTRODES. THE INTERFERENTIAL WAVEFORM WAS BEING USED AT INTENSITY OF 64 MILLIAMPS WITH NO MODULATED PULSE. THE LEADS HAD NOT BEEN REPLACED IN THE LAST 6 MONTHS. NO OINTMENT OR SOLVENT WAS APPLIED PRIOR TO ELECTRODES. THE DEVICE WAS POWERED DOWN WHEN THE ELECTRODES WERE MOVED. THEY HAVE READ THE INSTRUCTION MANUAL. THE BURNS ARE ONGOING, 2 WEEKS, AND THE PATIENT WAS REFERRED TO A WOUND SPECIALIST BY A NURSE. THEY WERE USING 4 ELECTRODES THAT WERE ABOUT 4 INCHES APART. FURTHER CLARIFIES THE SETTING AS '64V AT PRESET SETTINGS: 80HZ TO 150HZ FOR 1 MINUTE. THE PATIENT DID NOT HAVE METAL IMPLANTS, AS FAR AS THE END USER IS AWARE. 'THE ELECTRODES USED WERE 2" X 2" CLOTH SQUARE VALUTRODE ELECTRODES. ALL FOUR WERE PLACED 1.5" BILATERALLY OF THE SPINAL COLUMN AT LEVEL L3-L5, APPROXIMATELY 3 INCHES APART VERTICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005714 COMPASS HEALTH BRANDS THERATOUCH CX4 GZJ SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. CT2400(DQ8200)

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention