BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSARRAY2

    MDR report key: 603608 · Received April 12, 2005

    Report

    Report Number
    603608
    Event Type
    Malfunction
    Date Received
    April 12, 2005
    Date of Event
    April 11, 2005
    Report Date
    April 12, 2005
    Manufacturer
    PHYSIOMETRIX, INC.
    Product Code
    GXY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NEW PSA 4000 MONITORS HAVE BEEN PURCHASED BY THE HOSPITAL. THERE HAVE BEEN PROBLEMS NOTED WITH THE PHYSIOMETRIX EEG ELECTRODE SETS. IF THE ELECTRODE DISCONNECTS THE DEVICE STILL DISPLAYS THE LAST NUMBER. THE ELECTRODES DO NOT WORK WITH THE PATIENTS IN A PRONE POSITION OR IF THE ELECTRODES LIFT SLIGHTLY. THE MONITOR WILL STILL SHOW THE LAST NUMBER DISPLAYED. THE PRACTITIONER WAS ABLE TO GET A READING FROM A PROBE PLACED ON THE PRACTITIONER'S OWN HAND. THE MACHINE DOES NOT SHUT DOWN OR RECORD, BUT WILL DISPLAY THE LAST NUMBER THAT IT HAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PSARRAY2 EEG ELECTRODE SET GXY PHYSIOMETRIX, INC. * *
    2 PSA 4000 EEG MONITOR GWQ PHYSIOMETRIX, INC. PSA 4000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *