BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRX-REVOLUTION MOBILE X-RAY SYSTEM

    MDR report key: 10767051 · Received October 30, 2020

    Report

    Report Number
    1317307-2020-00009
    Event Type
    Injury
    Date Received
    October 30, 2020
    Date of Event
    October 7, 2020
    Report Date
    October 28, 2020
    Manufacturer
    CARESTREAM HEALTH INC.
    Product Code
    IZL
    PMA / PMN Number
    K191025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT RELATED TO THIS REPORT OCCURRED IN (B)(6). AS THIS INCIDENT WAS REPORTED TO THE (B)(6) COMPETENT AUTHORITY, (B)(6) IS REPORTING TO THE US FDA. THE CUSTOMER SITE ALLEGED THAT WHILST WAITING FOR THE ELEVATOR (LIFT), THE OPERATOR MOVED THE DRX REVOLUTION TO THE SIDE OF THE LIFT: THE OPERATOR WAS NOW BETWEEN THE REVO AND THE LIFT WALL. AFTER A TROLLEY BED WAS MOVED INTO THE ELEVATOR, THE OPERATOR TRIED TO PUSH THE REVO FORWARD TO REPOSITION THE SYSTEM IN ORDER TO GIVE HIMSELF ENOUGH SPACE TO MANEUVER AND REVERSE INTO AN ELEVATOR, THE OPERATOR ALLEGED THAT THE DRX REVOLUTION SYSTEM JERKED BACKWARD INSTEAD OF FORWARD AND PINNED HIM BETWEEN THE WALL AND SYSTEM. THERE WAS NO PATIENT INVOLVEMENT. CARESTREAM HEALTH HAS EVALUATED THE DEVICE AND DETERMINED THERE WAS NO DEVICE MALFUNCTION AND THE SYSTEM IS PERFORMING AS DESIGNED AND INTENDED. THE INVESTIGATION FOUND THAT THERE WERE NO DEVICE MALFUNCTIONS AND THE INCIDENT WAS CAUSED BY THE USER NOT FOLLOWING THE INSTRUCTIONS FOR USE (IFU). PER THE IFU, THE OPERATOR MUST USE BOTH HANDS AND DRIVE BEHIND THE DRX REVOLUTION IN ORDER TO PREVENT INJURY. THE FE INVESTIGATION CONFIRMED THAT THE OPERATOR WAS USING ONE (1) HAND PLACED ON THE CENTER OF THE DRIVE HANDLE AND DID NOT USE BOTH HANDS TO DRIVE THE DRX REVOLUTION AS SPECIFIED IN THE IFU. CARESTREAM HEALTH REPRESENTATIVES REITERATED TO THE SITE THE IMPORTANCE OF FOLLOWING THE DRIVING INSTRUCTIONS PROVIDED WITHIN THE INSTRUCTIONS FOR USE. THERE ARE NO FURTHER ACTIONS TO BE TAKEN BY CARESTREAM HEALTH RELATED TO THIS ISSUE. SINCE THIS DEVICE (S/N (B)(4)) WAS MANUFACTURED PRIOR TO UDI REQUIREMENTS ONLY A S/N IS RECORDED..

    Description of Event or Problem · 1

    THE CUSTOMER (B)(6) SITE ALLEGED THAT WHILST WAITING FOR THE ELEVATOR (LIFT), AN OPERATOR POSITIONED HIMSELF BACK, FACING THE ELEVATOR DOOR WITH THE DRX-REVOLUTION SYSTEM (ALSO KNOWN AS REVO) IN FRONT OF HIM. PER THE SITE, THIS IS NORMAL PRACTICE FOR THE OPERATOR WAITING FOR THE LIFT TO POSITION THEMSELVES IN ORDER TO REVERSE INTO THE ELEVATOR AND HAVE AN EASY EXIT LATER. WHEN THE OPERATOR SAW A TROLLEY BED APPROACHING WITH THE INTENT TO TAKE THE ELEVATOR AS WELL, HE MOVED THE DRX REVOLUTION TO THE SIDE OF THE LIFT: THE OPERATOR WAS NOW BETWEEN THE REVO AND THE LIFT WALL. AFTER THE TROLLEY BED MOVED INTO THE ELEVATOR, THE OPERATOR TRIED TO PUSH THE REVO FORWARD TO REPOSITION THE SYSTEM IN ORDER TO GIVE HIMSELF ENOUGH SPACE TO MANOEUVRE IT (THE REVO) AND REVERSE IN. HOWEVER, THE OPERATOR ALLEGED THAT THE SYSTEM JERKED BACKWARD INSTEAD OF FORWARD AND PINNED HIM BETWEEN THE WALL AND SYSTEM. HE PRESSED THE HANDLEBAR AGAIN AND MANAGED TO FREE HIMSELF. HE SUSTAINED A SMALL SCRATCH AND SOME REDNESS AROUND THE LOWER ABDOMEN. THE NEXT DAY HE NOTICED THERE WAS BRUISING AROUND THE ABDOMEN AREA AND SOUGHT MEDICAL ATTENTION AT THE STAFF CLINIC. X-RAYS WERE PERFORMED ON HIS PELVIS AND HIP; HOWEVER, THE INCIDENT DID NOT RESULT IN A SERIOUS INJURY AS THERE WERE NO FRACTURES. THE INCIDENT RESULTED IN A MINOR INJURY: HEMATOMA (BRUISE) ON THE HIP. THE OPERATOR WAS ON 3 DAYS MEDICAL LEAVE AND HAS SINCE RETURNED TO WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1225327 DRX-REVOLUTION MOBILE X-RAY SYSTEM MOBILE SYSTEM IZL CARESTREAM HEALTH INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other