BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCR CORADO

    MDR report key: 1180511 · Received May 23, 2008

    Report

    Report Number
    1217116-2008-00037
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    April 21, 2008
    Report Date
    April 24, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS X-RAY SYSTEM HAD ISSUES RELATED TO MISSING IMAGES THAT APPEARED SUPERIMPOSED ON OTHER PT'S IMAGES. THIS LOOKED LIKE DOUBLE EXPOSURES. THE ORIGINAL SHOWED IN EXPORT QUEUE AS GOING TO PICTURE ARCHIVING COMMUNICATIONS SYSTEM, PACS, BUT WERE NOT UNDER PT LISTING ON THE PHILIPS COMPUTED RADIOGRAPHY, PCR. AT LEAST ONE IMAGE ON THE PACS WAS UNDER ANOTHER PT'S FOLDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCR CORADO LLZ (IMAGE PROCESSING SYSTEM) LLZ PHILIPS MEDICAL SYSTEMS MCR1121 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA