BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS BRILLANCE 64 CT

    MDR report key: 1081161 · Received July 23, 2008

    Report

    Report Number
    MW5007773
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 23, 2008
    Manufacturer
    PHILIPS MEDICAL
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS A STEROID PREP FOR CONTRAST ALLERGY AND WAS BEING GIVEN I.V. CONTRAST FOR C.T. ANGIO. STUDY. THE CT SCANNER MALFUNCTIONED SHORTLY AFTER CONTRAST INJECTED AND STOPPED SCANNING. THE ERROR MESSAGE DISPLAYED WAS "THE GANTRY CAN'T COMPLY ERROR" AND STOPPED SCANNING. THIS WAS A CRITICAL PT THAT WILL HAVE TO BE PREPPED AGAIN AND EXPOSED TO ADD'L CONTRAST AND RADIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS BRILLANCE 64 CT CT SCANNER JAK PHILIPS MEDICAL BRILLANCE 64 CT

    Patients

    Seq Age Sex Outcome Treatment
    1