BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERDOT

    MDR report key: 10240291 · Received July 7, 2020

    Report

    Report Number
    3012282682-2020-00001
    Event Type
    Malfunction
    Date Received
    July 7, 2020
    Date of Event
    June 12, 2020
    Report Date
    June 12, 2020
    Manufacturer
    SMARTMISSIMO TECHNOLOGIES PTE LTD
    Product Code
    NGX
    UDI-DI
    14719872330387
    PMA / PMN Number
    K172876
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EVENT WAS CONFIRMED; MELTING OF THE DEVICE AT THE USB CHARGER CONNECTION POINT WAS OBSERVED. THE INITIAL DEVICE EVALUATION IDENTIFIED THAT THE UNIT WAS HEAVILY COATED WITH AN OILY SUBSTANCE, CONFIRMED BY THE PATIENT TO BE AN ARTHRITIC CREAM, VOLTAREN. THE SUBSTANCE WAS OBSERVED ON ALL CABLES AND WITHIN THE PINS OF THE MALE (DEVICE) END OF THE CABLE. INSPECTION OF THE USB SOCKET SOLDERING POINT, THE BATTERY, AND THE PCB DID NOT IDENTIFY DEFECTS OR EVIDENCE OF A SHORT CIRCUIT THAT WOULD CAUSE OVERHEATING. THE PRESENCE OF A CONDUCTIVE FOREIGN SUBSTANCE WITHIN THE PINS OF USB CHARGING CABLE COULD CAUSE A SHORT CIRCUIT RESULTING IN HIGH HEAT GENERATION DURING THE CHARGING PROCESS. THEREFORE, THE EVENT IS SUSPECTED TO BE CAUSED BY THE PATIENTS USE OF A FOREIGN SUBSTANCE WHILE HANDLING THE DEVICE RESULTING IN OVERHEATING. PRODUCT LABELING ALREADY WARNS AGAINST ALLOWING FOREIGN SUBSTANCES TO GET INTO THE DEVICE. THIS TYPE OF EVENT WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT DURING USE, THE UNIT STIMULATION WAS "CUTTING OFF". THE PATIENT REPORTED THAT HE THOUGHT THE ISSUE WAS DUE TO THE DEVICE NEEDING TO BE CHARGED. THE PATIENT CHARGED THE DEVICE AND MINUTES AFTER PLUGGING IN TO CHARGE, THE PATIENT SMELLED AN ELECTRICAL SMELL AND OBSERVED THE DEVICE PLASTIC MELTING AT THE USB PORT. WHEN THE PATIENT DISCONNECTED THE USB CABLE FROM THE DEVICE, THE DEVICE USB PORT DISCONNECTED FROM THE DEVICE. THE PATIENT PROVIDED PHOTOS VIA EMAIL. THE PATIENT REPORTED THAT THERE WAS NO INJURY OR DAMAGE TO PROPERTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707010 POWERDOT POWERED MUSCLE STIMULATOR NGX SMARTMISSIMO TECHNOLOGIES PTE LTD POWERDOT 2.0 1902 14719872330387

    Patients

    Seq Age Sex Outcome Treatment
    1