BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTROLSEAL ELECTRODE

    MDR report key: 17772547 · Received September 19, 2023

    Report

    Report Number
    3010605876-2023-00001
    Event Type
    Injury
    Date Received
    September 19, 2023
    Date of Event
    April 25, 2023
    Report Date
    May 16, 2023
    Manufacturer
    COAPT LLC
    Product Code
    GXY
    UDI-DI
    B618P1
    PMA / PMN Number
    K223605
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PROSTHETIC MANUFACTURER INDICATED THAT THE HEAT GENERATED BY THE BENT BATTERY WAS CONDUCTED THROUGH COAPT DOME ELECTRODES. COAPT REPLACED THE CONTROLLER DEVICE OUT OF AN ABUNDANCE OF CAUTION THAT THE DEVICE WAS POSSIBLE EXPOSED TO HEAT ABOVE OPERATING TEMPERATURE OF 95°F, DESPITE WORKING AS NORMAL. HEAT CONDUCTION IS AN INHERENT RISK OF METAL ELECTRODES, THE CAUSE OF THE HEAT WAS NOT DUE TO COAPT PRODUCTS.

    Description of Event or Problem · 0

    PATIENT THERMAL BURN ON RESIDUAL LIMB DURING PROSTHESIS WEAR. AFTER ABOUT 8 HOURS OF CONTINUED USE, PATIENT DOFFED HIS PROSTHETIC DEVICE AND NOTICED THERMAL BLISTERS ON HIS RESIDUAL LIMB. UPON FURTHER INSPECTION, HE FOUND CONSISTENT HOT SPOTS WITH WHERE OTHER SENSORS WERE ON THE LEFT SIDE OF HIS LIMB. HE ALSO NOTICED THAT THE BATTERY ON THAT SIDE SEEMED TO HAVE HEATED UP OR INDENTED THE SOCKET. PATIENT DID NOT FEEL ANY SENSATION OF HEAT, AND HAD HIS PROSTHETIC IN "FREEZE MODE". PATIENT CONFIRMS HE WAS NOT IN DIRECT HEAT WHILE WEARING THE PRODUCT, INDICATING THAT ENVIRONMENTAL HEAT EXPOSURE WAS NOT A LIKELY CAUSE. PATIENT RETURNED THE PROSTHETIC ARM SYSTEM TO HIS PROSTHETIST (CLINICIAN) WHO SUBSEQUENTLY SEND IT TO THE PROSTHETIC HAND AND BATTERY MANUFACTURER, PSYONIC (SAN DIEGO, CA, HTTPS://WWW.PSYONIC.IO/) FOR DIAGNOSIS AND INSPECTION. THE INVESTIGATION BY THE PROSTHETIC HAND AND BATTERY MANUFACTURER, PSYONIC (SAN DIEGO, CA, HTTPS://WWW.PSYONIC.IO/) DETERMINED THAT A PSYONIC BATTERY UNIT INSTALLED INSIDE THE PROSTHETIC ARM SYSTEM BECAME BENT, WHICH CAUSED THIS BATTERY DAMAGE; INTERNAL DAMAGE WITHIN THE BATTERY UNIT RESULTING IN THE BATTERY CELL OVERHEATING. PSYONIC'S INVESTIGATION SHOWED THAT THE BENDING WAS LIKELY CAUSED BY INSUFFICIENT SPACE WITHIN THE DEVICE AND THE FORCE OF THE PATIENT'S RESIDUAL LIMB AGAINST THE BATTERY WHILE DONNING THE PROSTHETIC. THE EXCESSIVE HEAT PRODUCED BY THE DAMAGED BATTERY WOULD HAVE BEEN IN CLOSE PROXIMITY TO COAPT'S ELECTRODES, AND THE HEAT WOULD HAVE BEEN CONDUCTED FROM THE EXTREME CONDITION TO THE PATIENTS' SKIN THROUGH THE METAL OF THE ELECTRODES, RESULTING IN THE MINOR BURNS INCURRED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1880033 CONTROLSEAL ELECTRODE CUTANEOUS EMG ELECTRODE GXY COAPT LLC B618P1

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other