BEUDAMED
    FDA Adverse Event Summary report: N

    DISCOVERY

    MDR report key: 4062554 · Received August 18, 2014

    Report

    Report Number
    4062554
    Date Received
    August 18, 2014
    Date of Event
    June 20, 2014
    Report Date
    August 18, 2014
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    KPS
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    GE SERVICE ENGINEER ON SITE TO PERFORM QUARTERLY PREVENTIVE MAINTENANCE (PM) SERVICE TO PET/CT SCANNER. DURING THE COURSE OF HIS SERVICE, THE MACHINE WENT INTO A SHUTDOWN MODE. AFTER CHECKING WITH HIS ONLINE SERVICE CENTER, IT WAS DECIDED THE ONLY CORRECTIVE ACTION TO BE TAKEN WAS TO POWER THE MACHINE DOWN, WHICH WOULD RESULT IN A TOTAL LOSS OF ALL ACQUIRED PATIENT/SCAN DATABASE. THIS ACTION HAS RESULTED IN THE NEED TO REPEAT THREE PATIENT PROCEDURES PERFORMED THAT DAY. DUE TO THE CRASH OF THE HOSPITAL PATIENT DATA NETWORK, THE SCANS WERE NOT ABLE TO BE PROCESSED WHEN THEY WERE COMPLETED. THE PM SERVICE WAS BEGUN PRIOR TO NETWORK BEING RESTORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496297 DISCOVERY SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION KPS GE MEDICAL SYSTEMS, LLC DST *

    Patients

    Seq Age Sex Outcome Treatment
    1 *