BEUDAMED
    FDA Adverse Event Summary report: N

    BIOMEDICAL IMPULSE 2000 TENS UNIT

    MDR report key: 3020807 · Received March 20, 2013

    Report

    Report Number
    MW5029459
    Date Received
    March 20, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 20, 2013
    Manufacturer
    BIOMEDICAL LIFE SYSTEMS INC.
    Product Code
    GZJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICAL THERAPIST PLACED ELECTRODES CONNECTED TO E-STIM DEVICE OVER THE PT'S LEFT KNEE AREA. ONCE THE MACHINE WAS TURNED ON, THE THERAPIST SMELLED SMOKE AND IMMEDIATELY TURNED OFF THE DEVICE AND DISCONNECTED THE UNIT FROM THE PT. THE PT DID NOT SUSTAIN ANY INJURY. THERE WERE NO CHANGES TO THE SKIN NOR DID THE PT COMPLAIN OF ANY PAIN. THE FACILITY'S BIO-MEDICAL DEPARTMENT PERFORMED AN INSPECTION THAT REVEALED "SMOKE" BEING GENERATED BY THIS DEVICE IMMEDIATELY WHEN IT WAS TURNED ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115754 BIOMEDICAL IMPULSE 2000 TENS UNIT NERVE STIMULATOR GZJ BIOMEDICAL LIFE SYSTEMS INC. B59577-2006J

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR