BEUDAMED
    FDA Adverse Event Other Summary report: N

    DRX-REVOLUTION MOBILE X-RAY SYSTEM

    MDR report key: 2823619 · Received November 2, 2012

    Report

    Report Number
    1317307-2012-00009
    Event Type
    Other
    Date Received
    November 2, 2012
    Date of Event
    September 19, 2012
    Report Date
    November 2, 2012
    Manufacturer
    CARESTREAM HEALTH, INC.
    Product Code
    IZL
    PMA / PMN Number
    K120062
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE ANALYSIS AND OBSERVATION OF THE USER PERFORMING PT EXAMS LED TO A CONCLUSION THAT THE USER WAS INADVERTENTLY COMING INTO CONTACT WITH THE TUBE HEAD TOUCH SCREEN DURING POSITIONING OF THE TUBE HEAD. THIS RESULTED IN INADVERTENT SELECTIONS BY THE USER ON THE TOUCH SCREEN. THE USER WAS POSITIONING THE TUBE HEAD FROM BEHIND IT BECAUSE OF SPACE LIMITATIONS - SO THE TOUCH SCREEN WAS NOT IN VIEW. THEREFORE THE USER DID NOT SEE THE SCREEN CHANGE. ALL PT IMAGES WERE LOCATED AND CORRECTLY FILED WITH THE HELP OF A CARESTREAM SERVICE ENGINEER. THE TUBE HEAD TOUCH SCREEN WAS DISCONNECTED ON ALL THREE UNITS AT THE REQUEST OF THE SITE. THE SITE HAS HAD NO RECURRENCES SINCE THE TUBE HEAD TOUCH SCREENS WERE DISCONNECTED. A SOFTWARE UPGRADE WILL BE RELEASED TO ALLOW THE USER TO CONFIGURE THE TOUCH SCREEN TO BE NON-OPERATIONAL SO THAT THE WORK AROUND TO PHYSICALLY DISCONNECT THE TOUCH SCREEN WILL NO LONGER BE NECESSARY. OTHER IMPROVEMENTS ARE BEING CONSIDERED. ADDITIONAL SERIAL NUMBERS: (B)(4).

    Description of Event or Problem · 1

    A BIOMED AT THE SITE CALLED TO REPORT 3 UNITS WITH THE SAME PROBLEM. THE BIOMED REPORTED THAT WHEN THE TUBE HEAD ASSEMBLY IS MOVED, OR IF THE UNIT IS MOVED, THE PT CHANGES ON THE SCREEN. THE BIOMED ALSO REPORTED THAT THEY HAD SELECTED A PT RECORD, TAKEN EXPOSURES, AND THEN WERE UNABLE TO FIND THE PT IMAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRX-REVOLUTION MOBILE X-RAY SYSTEM MOBILE X-RAY SYSTEM IZL CARESTREAM HEALTH, INC. DRXR-1

    Patients

    Seq Age Sex Outcome Treatment
    1