BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNISTIM STIMULATOR

    MDR report key: 31230 · Received March 14, 1996

    Report

    Report Number
    MW1008626
    Event Type
    Malfunction
    Date Received
    March 14, 1996
    Date of Event
    February 2, 1996
    Report Date
    March 7, 1996
    Manufacturer
    PHISIO TECHNOLOGIES, INC.
    Product Code
    GZJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE PT WAS RECEIVING TREATMENT FROM A STIMULATOR, THE UNIT SENT STRONG AMOUNTS OF MILLIAMPS. THE OUTPUT BUTTON WAS NEVER TOUCHED. THE TRANSMISSION WAS PRODUCTED FROM TURNING THE MACHINE ON ONLY. EQUIPMENT WAS DETERMINED TO BE MALFUNCTIONING. THE PT WAS TREATED WITH A HOT PACK. THERE WAS NO SKIN DISCOLORATION OR INJURY OTHER THAN A TEMPORARY SHOCK THROUGH 4 ELECTRODES PLACED OVER HER LOW BACK BILATERALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNISTIM STIMULATOR STIMULATOR GZJ PHISIO TECHNOLOGIES, INC. 500

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR