BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINUM ONE CARDIAC

    MDR report key: 1033477 · Received April 23, 2008

    Report

    Report Number
    1318879-2008-00001
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    March 26, 2008
    Report Date
    April 23, 2008
    Manufacturer
    INFIMED, INC.
    Product Code
    JAA
    PMA / PMN Number
    012490
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORIGINAL TOWER WAS RECEIVED ON 4/02/2008 AT INFIMED FOR EVALUATION AND HAS BEEN PERMANENTLY REMOVED FROM SERVICE. INFIMED ENGINEERING WAS NOT ABLE TO REPRODUCE THE FAILURE DURING EVALUATION OF THE RETURNED SYSTEM TOWER. HOWEVER, IT WAS DETERMINED THAT THE "LOST" IMAGES WERE STILL ON THE SYSTEM RAID DRIVE IN A RECOVERABLE STATE. THESE IMAGES WERE EXPORTED TO DICOM MEDIA AND THEN RETURNED TO KAISER FONTANA. THE LOG FILES OF BOTH THE WINDOWS OPERATING SYSTEM AND THE P1 CARDIAC SOFTWARE WERE COLLECTED AND REVIEWED. THEY DID NOT PROVIDE ANY INDICATION OF WHY THE SYSTEM PRODUCED THE ERROR OTHER THAN THE 'CRASH.LOG' RECORDED AN EVENT AT THE APPROXIMATE TIME OF THE INCIDENT. BASED ON THIS INFORMATION, THE CORRESPONDING SOURCE CODE OF THE P1 CARDIAC WAS THOROUGHLY INSPECTED TO DETERMINE IF THERE WERE ANY CONFLICTS THAT COULD HAVE CAUSED THE ERROR. NONE WERE FOUND. A POSSIBLE CAUSE MAY HAVE BEEN MEMORY CORRUPTION THAT WAS MANIFESTED AND EVENTUALLY COULD NOT BE HANDLED ANY LONGER BY THE SYSTEM.

    Description of Event or Problem · 1

    IN 2008, AFTER ACQUIRING 6 SEQUENCES DURING A CARDIAC PROCEDURE, AN ERROR MESSAGE WAS DISPLAYED THAT WAS THE RESULT OF A SYSTEM MALFUNCTION CAUSING WINDOWS TO RESTART. AFTER WINDOWS RESTARTED, THUMBNAIL IMAGES WERE PRESENT, BUT NO ACQUIRED IMAGES WERE AVAILABLE. AFTER A SECOND REBOOT, NO THUMBNAIL IMAGES WERE PRESENT EITHER. THE TECHNICIAN WAS UNABLE TO VIEW ANY IMAGES. SINCE THIS PROCEDURE WAS REQUIRED IN PREPARATION FOR SURGERY, THE IMAGES WERE ACQUIRED AGAIN (RE-EXPOSING THE PATIENT TO X-RAY) BEFORE ANY SYSTEM EVALUATION. THESE NEW IMAGES WERE REVIEWED AND THE EVALUATION WAS COMPLETED. THE X-RAY TECHNICIAN REPORTED THE MALFUNCTION TO INFIMED AFTER NOTICING THAT THE 2 NEW RUN SEQUENCES SEEMED TO BE INCORRECTLY IDENTIFIED AS THE FIRST 2 RUNS. THE SYSTEM PERFORM AS EXPECTED FOR 2 MORE DAYS WHILE UNDER EVALUATION BY THE SITE X-RAY TECHNICIAN. AN INFIMED TECHNICAL SUPPORT ENGINEER ARRIVED AT THE SITE TWO DAYS LATER TO INSTALL A REPLACEMENT TOWER AND RETURN THE ORIGINAL TOWER TO INFIMED. THE INFIMED ENGINEER REMAINED ON SITE UNTIL THE FOLLOWING MONTH TO OBSERVE ALL CASES DURING THAT PERIOD. NO ISSUES WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLATINUM ONE CARDIAC IMAGE-INTENSIFIED FLUORO X-RAY SYSTEM JAA INFIMED, INC. P1 CARDIAC

    Patients

    Seq Age Sex Outcome Treatment
    1