BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPER INFORMATION MANAGEMENT PHYSIOMONITORING 5 SYSTEM

    MDR report key: 3962822 · Received July 17, 2014

    Report

    Report Number
    3962822
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    April 3, 2014
    Report Date
    July 17, 2014
    Manufacturer
    WITT BIOMEDICAL CORPORATION
    Product Code
    MWI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THE XPER RECORDING SYSTEM WAS USED TO DOCUMENT AN ELECTROPHYSIOLOGY CASE. WHEN TECH TRIED TO LOOK UP THE DOCUMENTATION FOR THE CASE, NOTED THAT THERE WAS NO DOCUMENTATION FOR THE CASE IN THE COMPUTER. TECH THEN CHECKED WITH TWO OTHER TECHS AND THEY BOTH AGREED THE CASE WAS RECORDED IN THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420447 XPER INFORMATION MANAGEMENT PHYSIOMONITORING 5 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE MWI WITT BIOMEDICAL CORPORATION HOST PC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 *