BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINUM ONE CARDIAC

    MDR report key: 921806 · Received March 28, 2007

    Report

    Report Number
    1318879-2007-00002
    Event Type
    Malfunction
    Date Received
    March 28, 2007
    Date of Event
    March 19, 2007
    Report Date
    March 28, 2007
    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 PHYSICIAN WAS ABLE TO COMPLETE PATIENT DIAGNOSIS WITH AVAILABLE ON-SCREEN IMAGES FOR ALL 8 RUNS. INFIMED SENIOR TECHNICAL SUPPORT ENGINEER, INSTRUCTED HOSPITAL RADIOLOGY TECHNICIAN, NOT TO USE THIS SYSTEM UNTIL PROPERLY TESTED AND ANALYZED BY INFIMED. ENGINEER INSTALLED THE LATEST SOFTWARE VERSION 03/21/2007 AT THE SITE AND THE SYSTEM IS OPERATING NORMALLY AFTER CASES. NOTE THAT INFIMED TECHNICAL SUPPORT ENGINEER, HAD PREVIOUSLY BEEN TO THIS KAISER SITE IN JANUARY 2007 AND RECOMMENDED THE OPTIONAL SOFTWARE UPGRADE. THE SITE DECLINED TO UPGRADE STATING THAT THIS WAS NOT NECESSARY SINCE THE SYSTEM HAD BEEN OPERATING NORMALLY. THIS FIELD CHANGE ORDER HAS NOW BEEN REVISED TO REQUIRE A SOFTWARE UPGRADE FOR ALL APPLICABLE SITES.

    Description of Event or Problem · 1

    AT THE END OF THE PATIENT CASE, THE RADIOLOGY TECHNICIAN NOTED THAT THEY WERE MISSING THE LAST 2 RUN THUMB-NAIL IMAGES. THE LAST 2 RUNS WERE COMPLETED BY THE DOCTOR. THE RADIOLOGY TECHNICIAN EXITED THE PATIENT FILE TO SEE IF THEY COULD GET THE RUNS TO DISPLAY. THE SITE THEN NEEDED TO REBOOT ("CONTROL / ALT / DELETE") BECAUSE THE SYSTEM WAS NOT RESPONDING. THEY RE-STARTED THE APPLICATION AND ONLY 1 OF THE 2 LAST RUNS WAS FOUND TO BE ON THE SYSTEM.

    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 *