BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPER PC

    MDR report key: 3965914 · Received July 17, 2014

    Report

    Report Number
    3965914
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    April 8, 2014
    Report Date
    July 16, 2014
    Manufacturer
    WITT BIOMEDICAL CORPORATION
    Product Code
    DQK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    DURING A CARDIAC CATH PROCEDURE A BLOOD GAS RESULT WAS ENTERED INTO THE PHILIPS XPER SYSTEM IN CATH LAB AND LATER WAS MISSING WHEN THE RESULTS WERE NEEDED PRIOR TO FINISHING THE CASE. THE BLOOD GAS RESULT WAS TYPED INTO THE HEMODYNAMICS PAGE A SECOND TIME AND WAS MISSING FROM THE DATA PAGE APPROXIMATELY 15 MINUTES LATER. DUE TO THE EMERGENT NATURE OF THE CASE, XPER COULD NOT BE CALLED DURING THE PROCEDURE. TWO DAYS LATER ANOTHER BLOOD GAS RESULT WAS PLACED INTO THE SYSTEM AND LATER NOTED THAT IT WAS MISSING WHEN THE TECH TRIED TO REVIEW THE INFORMATION. XPER CUSTOMER SERVICE WAS CALLED ABOUT BOTH OF THESE INCIDENTS AND PLANS TO FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420274 XPER PC COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK WITT BIOMEDICAL CORPORATION HOST PC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 *