BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISCOVERY CT750 HD

    MDR report key: 1903552 · Received November 15, 2010

    Report

    Report Number
    1903552
    Event Type
    Malfunction
    Date Received
    November 15, 2010
    Date of Event
    August 24, 2010
    Report Date
    November 12, 2010
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT COMPUTED AXIAL TOMOGRAPHY SCANNED WITH INCORRECT TECHNICAL FACTORS RESULTING IN INCREASED RADIATION DOSE TO PATIENT. PATIENT ORIENTATION IN SCANNER CHANGED FROM FEET-FIRST TO HEAD-FIRST DUE TO ANESTHESIA ADMINISTRATION. MANUAL CHANGES TO PROTOCOL RESULTED IN SYSTEM DISABLING AUTO-MA AND DELIVERING 770 MA. SOFTWARE COMMUNICATION NOT CLEAR TO TECHNICAL STAFF THAT AUTO-MA WAS DISABLED, CHANGE IN MA WAS NOT RECOGNIZED. ISSUE NOT RECOGNIZED AT TIME OF SCAN - DISCOVERED APPROXIMATELY ONE MONTH LATER DURING A ROUTINE AUDIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISCOVERY CT750 HD CT SCANNER JAK GE MEDICAL SYSTEMS, LLC DISCOVERY CT750 HD *

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO