BEUDAMED
    FDA Adverse Event Summary report: N

    EPOCH XP

    MDR report key: 1865027 · Received September 28, 2010

    Report

    Report Number
    1865027
    Date Received
    September 28, 2010
    Date of Event
    May 11, 2010
    Report Date
    September 28, 2010
    Manufacturer
    AXON SYSTEMS
    Product Code
    GWE
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE TECHNICIAN PLACED THE UNIT AT THE FRONT OF THE HEAD OF THE PATIENT; THE UNIT IS MANUFACTURED WITHOUT PROTECTION OF OVERSPRAY FROM SUCTION IRRIGATION SO WHEN THE UNIT WAS SPRAYED, IT SHORTED OUT SOME OF THE ELECTRODES AND CAUSED FIRST DEGREE BURNS TO THE PATIENT'S EAR, BACK AND SCALP.======================HEALTH PROFESSIONAL'S IMPRESSION======================DID NOT REALIZE THE UNIT WAS NOT COVERED BY THE STERILE DRAPING; THEREFORE, DID NOT NOTICE THE BURNING TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPOCH XP STIMULATOR, PHOTIC, EVOKED RESPONSE GWE AXON SYSTEMS EPOCH XP *

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR