BEUDAMED
    FDA Adverse Event Other Summary report: N

    KODAK DIRECTVIEW DR 9500 SYSTEM

    MDR report key: 1512103 · Received October 20, 2009

    Report

    Report Number
    1317307-2009-00005
    Event Type
    Other
    Date Received
    October 20, 2009
    Date of Event
    September 21, 2009
    Report Date
    October 20, 2009
    Manufacturer
    CARESTREAM HEALTH, INC.
    Product Code
    KPR
    PMA / PMN Number
    K051258
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODE FOR METHOD CONSISTED OF ANALYSIS OF LOG FILES OF THE INCIDENT FROM THE ACTUAL DEVICE INVOLVED IN THE INCIDENT. A SOFTWARE PATCH IS BEING DEVELOPED TO CORRECT THE DEFECT AT AFFECTED CUSTOMER SITES. IF DETERMINED TO BE NECESSARY, A CUSTOMER COMMUNICATION WILL BE ISSUED ONCE THE AFFECTED SOFTWARE VERSIONS ARE IDENTIFIED. ANALYSIS OF LOG FILES FROM MULTIPLE SITES INDICATES THAT THE FREQUENCY OF OCCURRENCE OF THE PRECIPITATING EVENT IS EXTREMELY LOW (LESS THAN 0.002% PROBABILITY OF OCCURRENCE).

    Description of Event or Problem · 1

    THE PATIENT INFORMATION WAS ENTERED ON THE DR CONSOLE AND THE "BEGIN STUDY" BUTTON WAS SELECTED. A POP-UP MESSAGE: "AN ATTEMPT TO REVERT BACK TO THE PREVIOUS ACTIVE DETECTOR FAILED. WARNING: THE SYSTEM WILL NOW REVERT TO STANDALONE MODE WHERE NO DETECTOR IS SELECTED. IF PROBLEM PERSISTS, PLEASE CONTACT TECHNICAL SUPPORT CENTER." WAS DISPLAYED. HOWEVER, THE DR 9500 DISPLAY SHOWED THAT A DETECTOR WAS SELECTED. THE OPERATOR DISMISSED THE POP-UP, POSITIONED THE PATIENT FOR AN AP ABDOMINAL X-RAY, AND TOOK THE EXPOSURE. THE IMAGE THAT APPEARED ON THE DR 9500 DISPLAY WAS A KNEE IMAGE FROM THE PREVIOUS PATIENT ALONG WITH THE PATIENT INFORMATION FOR THE AP ABDOMINAL EXAM (CURRENT PATIENT). THE CORRECT TECHNIQUE SETTINGS FOR THE PA ABDOMINAL EXAM WERE ALSO DISPLAYED. THE SYSTEM WAS OBSERVED TO PREP AND EXPOSE AS EXPECTED FOR THE AP ABDOMINAL EXAM. THE EXPOSURE WAS CARRIED OUT AS EXPECTED BUT THE CURRENT PATIENT IMAGE WAS NOT CAPTURED. THE SAME WRONG IMAGE FROM THE LAST SUCCESSFUL EXPOSURE WAS DISPLAYED INSTEAD. THE HOSPITAL TECHNICIAN RECOGNIZED THAT A PROBLEM OCCURRED AND DID NOT ACCEPT THE WRONG PATIENT IMAGE FOR THE CURRENT PATIENT EXAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KODAK DIRECTVIEW DR 9500 SYSTEM DR 9500 KPR CARESTREAM HEALTH, INC. DR 9500

    Patients

    Seq Age Sex Outcome Treatment
    1 Other