BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DANTEC

    MDR report key: 5376730 · Received January 19, 2016

    Report

    Report Number
    3004827015-2016-00001
    Event Type
    Injury
    Date Received
    January 19, 2016
    Date of Event
    December 3, 2015
    Report Date
    January 19, 2016
    Manufacturer
    ALPINE BIOMED APS
    Product Code
    GWF
    PMA / PMN Number
    K944547
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    OUR COMPLAINT FILES SHOW NO PREVIOUS REPORTS OF SIMILAR INCIDENTS ON ANY OF OUR KEYPOINT SYSTEMS. THE USER MANUAL FOR THE G3 SYSTEM STATES THAT MAXIMUM CURRENT DENSITY DURING STIMULATION SHOULD NEVER EXCEED 2 MA RMS/CM² OR IT COULD CAUSE BURNS BUT THERE IS NO EVIDENCE THIS CURRENT DENSITY WAS EXCEEDED. WE CALCULATED THE MOST PROBABLE CURRENT DENSITY BASED ON THE INFORMATION PROVIDED BY THE END USER AND FOUND IT TO BE 0.263MA RMS/CM². ALL KEYPOINT SYSTEMS INCLUDE AN INTEGRATED TEST PROGRAM FOR HARDWARE WHICH ENSURES THE STIMULATOR WORKS CORRECTLY. THE STIMULATOR IS ALSO TESTED DURING EVERY STARTUP OF THE SOFTWARE.

    Description of Event or Problem · 1

    A (B)(6) PATIENT WITH SUSPECTED CELLULITIS WAS GIVEN AN NCV EXAM USING THE KEYPOINT G3 SYSTEM (ELECTRODES UNKNOWN)AND THEN WENT HOME. SHE RETURNED TO ER THE SAME NIGHT WITH A BULLA/BLISTER ON THE BACK OF HER LEG IN THE MIDDLE OF HER CALF, THIS IS THE GENERAL AREA WHERE STIMULATION WAS APPLIED DURING THE NCV TEST. THE REPORTER OF THE EVENT DESCRIBED THE BULLA AS A SECOND DEGREE BURN AND THE PATIENT IS THOUGHT TO REQUIRE SKIN GRAFTS. AT THE TIME OF THE EVENT, THE OPERATOR EQUIPMENT AND ITS EXAM SOFTWARE WERE CHECKED AND EVERYTHING IS NORMAL. THE INCIDENT OCCURRED ON (B)(6) 2015 AND END USER CONTINUED TO USE THE EQUIPMENT EVERY DAY FOR APPROXIMATELY 8-10 EXAMS A DAY. AT LAST CONTACT (JANUARY 8TH 2016) OUR DISTRIBUTION PARTNER REPORTED THAT NO SIMILAR PROBLEMS HAD OCCURRED AND THE HOSPITAL NEUROLOGIST DID NOT THINK THE BURN WAS CAUSED BY OUR EQUIPMENT BUT WANTED OUR HELP TO CLARIFY THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35943 DANTEC KEYPOINT G3 GWF ALPINE BIOMED APS 9031A0064

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other