BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTERTRON NEUROMUSCULAR STIMULATOR

    MDR report key: 35697 · Received August 16, 1996

    Report

    Report Number
    MW1009750
    Event Type
    Other
    Date Received
    August 16, 1996
    Date of Event
    July 10, 1996
    Report Date
    July 26, 1996
    Manufacturer
    WILLIAMS HEALTHCARE SYSTEMS
    Product Code
    GZJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICAL THERAPIST USING NEUROMUSCULAR STIMULATOR ON PT. LEFT PT WITH UNIT OPERATING FOR A REPORTED TIME PERIOD OF A FEW (45) SECS. PT YELLED FOR ASSISTANCE AND TECH LOOKED AT DISPLAY. SETTINGS HAD MOVED FROM 8/11 TO BEING 8/63. SHUT DOWN UNIT AND REMOVED ELECTRODES ON SIDE OF HER NECK. TESTED CALIBRATION WITH MFR (AND REVIEWED TESTING PROCEDURE). IDENTIFIED POSSIBILITY THAT PADS WERE DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERTRON NEUROMUSCULAR STIMULATOR TRANSCUTANEOUS NERVE STIMULATOR GZJ WILLIAMS HEALTHCARE SYSTEMS 5000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other