BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI STIM

    MDR report key: 35289 · Received July 23, 1996

    Report

    Report Number
    35289
    Event Type
    Malfunction
    Date Received
    July 23, 1996
    Date of Event
    February 2, 1996
    Report Date
    March 7, 1996
    Manufacturer
    PHYSIO TECHNOLOGIES, INC.
    Product Code
    IPF
    Product Problem
    Yes
    Report Source
    User Facility 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 PRODUCED FROM TURNING THE MACHINE ON ONLY. EQUIPMENT WAS DETERMINED TO BE MALFUNCTIONED. THE PT WAS TREATED WITH A HOT PACK. THERE WAS NO SKIN DISCOLORATION OR INJURIES OTHER THAN A TEMPORARY SHOCK THROUGH 4 ELECTRODES PLACED OVER HER LOW BACK MUSCULATURE BILATERALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNI STIM STIMULATOR IPF PHYSIO TECHNOLOGIES, INC. MF8025 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR