BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRX-REVOLUTION MOBILE X-RAY SYSTEM

    MDR report key: 12666718 · Received October 20, 2021

    Report

    Report Number
    1317307-2021-00007
    Event Type
    Injury
    Date Received
    October 20, 2021
    Date of Event
    September 22, 2021
    Report Date
    October 19, 2021
    Product Code
    IZL
    PMA / PMN Number
    K191025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CARESTREAM HEALTH HAS EVALUATED THE DEVICE AND DETERMINED THAT THE RIGHT AND LEFT STRAIN GAUGES WERE OUT OF BALANCE. THE LEFT AND RIGHT STRAIN GAUGES INDEPENDENTLY CONTROL THE SPEED OF ACCELERATION OF EACH OF THE DRIVE WHEELS. PUSHING HARDER ON THE DRIVE HANDLE ON ONE SIDE DEFLECTS THE FLEXURE ON THAT SIDE. THE STRAIN GAUGE MEASURES THE DEFLECTION AND ACCELERATES THE DRIVE WHEEL ON THAT SIDE FASTER. THE STRAIN GAUGES WERE RECALIBRATED AND RE-TESTED RESULTING IN NORMAL OPERATION. BOTH STRAIN GAUGES WERE REPLACED AS A PRECAUTIONARY MEASURE. THERE WAS NO PATIENT INVOLVEMENT. IN ADDITION, THE SITE TECH (USER) WAS NOT DRIVING THE SYSTEM AS SPECIFIED IN THE IFU, WITH BOTH HANDS ON THE DRIVE HANDLE. IT IS UNLIKELY, IF FOLLOWING THE DRIVING RECOMMENDATIONS PROVIDED WITHIN THE IFU, THAT THIS TYPE OF INJURY WOULD OCCUR. FOR UDI FIELD D4, THERE IS NO UDI NOTED. THE DRX REVOLUTION SYSTEM WAS MANUFACTURED IN FEBRUARY 2013 PRIOR TO UDI REQUIREMENT; THEREFORE, NO UDI IS PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2021, CARESTREAM HEALTH (CSH) WAS INFORMED OF AN INCIDENT RELATED TO THE DRX-REVOLUTION MOBILE X-RAY SYSTEM WHICH OCCURRED AT (B)(6) HOSPITAL - USA. THE SITE LEAD TECH, CHRISTINA, ALLEGED THAT ON (B)(6) 2021, WHILE DRIVING THE DRX REVOLUTION SYSTEM THROUGH A METAL DOORWAY, A TECH PINCHED HER FINGER IN THE DOORWAY. THIS RESULTED IN A CUT ON HER PINKY FINGER WHICH REQUIRED STITCHES. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1566671 DRX-REVOLUTION MOBILE X-RAY SYSTEM DRX-REVOLUTION MOBILE X-RAY SYSTEM IZL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other