BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL TENS UNIT, WITH 4 ELECTRODES

    MDR report key: 3788558 · Received April 4, 2014

    Report

    Report Number
    1060680-2014-00006
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    March 10, 2014
    Report Date
    April 4, 2014
    Manufacturer
    DEROYAL INDUSTRIES
    Product Code
    GZJ
    PMA / PMN Number
    K022841
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    I AM NOT QUITE SURE HOT TO DIRECT MY INVESTIGATION OF COMPLAINT RELATED TO THE UNIT "SHOCKING THE CUSTOMER. (AS THE UNITS INTENDED USE IS TO DELIVER AN ELECTRICAL SHOCK TO THE PT TO EASE PAIN) THE COMPLAINT SAMPLE WAS RETURNED, HOWEVER; THE BATTERY/WIRES/LEADS AND ELECTRODES WERE NOT RETURNED. I WAS ABLE TO POWER THE UNIT ON, CHANGE INTENSITY AND MODES WITH NO PROBLEM USING A NEW BATTERY THAT I ADDED. WIRES FROM AND ELECTRODES FROM A "TESTING UNIT" WERE PLACED ON THE PRODUCT. NO ISSUE WAS FOUND. POSSIBLY THE WIRES/LEADS OR ELECTRODES THAT THE CUSTOMER WAS USING WERE DAMAGED/DEFECTIVE. ROOT CAUSE ANALYSIS: UNABLE TO DETERMINE. POSSIBLE THE WIRES/LEADS OR ELECTRODES THAT THE CUSTOMER WAS USING WERE DAMAGED/DEFECTIVE. CORRECTIVE ACTION AND/OR SYSTEMIC CORRECTION ACTION TAKEN: NO ACTION REQUIRED, THE ENTIRE SAMPLE WAS NOT RETURNED FOR EVALUATION, NO VENDOR DEFECT WAS FOUND DURING...

    Description of Event or Problem · 1

    UNIT IS CAUSING SHOCK TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204361 DIGITAL TENS UNIT, WITH 4 ELECTRODES STIMULATOR, NERVE, TRANSCUTANEOUS GZJ DEROYAL INDUSTRIES GC21M-0016

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention