BEUDAMED
    FDA Adverse Event Summary report: N

    D-EVO SUITE II

    MDR report key: 5429238 · Received February 10, 2016

    Report

    Report Number
    2443168-2015-00007
    Date Received
    February 10, 2016
    Date of Event
    June 14, 2013
    Report Date
    October 6, 2015
    Manufacturer
    FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
    Product Code
    KPR
    PMA / PMN Number
    K013218
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE SIEMENS BUCKY WALL STAND TL CM IS A COMPONENT OF THE FUJIFILM FDR D-EVO SUITE II X-RAY SYSTEM. THE FDR D-EVO SUITE II IS SOLD AND DISTRIBUTED IN THE UNITED STATES BY FUJIFILM MEDICAL SYSTEMS U.S.A., INC. FMSU SUBMITTED THIS MDR (ALONG WITH THREE OTHER MDRS) ON OCTOBER 6, 2015. UNFORTUNATELY, THE SUBMISSION FAILED AND WE DID NOT REALIZE IT UNTIL LAST WEEK. WE ARE THEREFORE SUBMITTING IT TODAY. THE FOLLOWING IS THE ACKNOWLEDGMENT MESSAGE RECEIVED ON (B)(6) 2015: (B)(4). CDRH HAS RECEIVED YOUR SUBMISSION.

    Description of Event or Problem · 1

    FUJIFILM MEDICAL SYSTEMS U.S.A., INC. (FMSU) RECENTLY COMPLETED A RETROSPECTIVE REVIEW OF COMPLAINT FILES FROM 2013 THROUGH 2015 AND HAS DETERMINED THAT THIS COMPLAINT MAY MEET THE THRESHOLD FOR REPORTING BECAUSE THE USER STATED THERE WAS AN INJURY, ALTHOUGH THERE IS NO INFORMATION REGARDING THE EXTENT OF THE ALLEGED INJURY. FMSU IS THEREFORE REPORTING IT AT THIS TIME. IT HAS BEEN REPORTED THAT THE PATIENT STABILIZER BAR (ALSO KNOWN AS PATIENT STRETCH GRIP) OF THE UPRIGHT WALL BUCKY STAND SWUNG DOWN AND HIT A RADIOLOGY TECHNICIAN IN THE HEAD. THE BUCKY STAND IS MANUFACTURED BY SIEMENS AND SOLD BY FUJIFILM MEDICAL SYSTEMS U.S.A., INC. AS PART OF THE FDR D-EVO SUITE 2 RADIOGRAPHIC SYSTEM. FUJIFILM HAS BEEN UNABLE TO CORROBORATE THE DESCRIPTION ABOVE, AS THE SITE WOULD NOT PROVIDE AN INCIDENT REPORT OF THE ALLEGED INCIDENT. CUSTOMER SOLUTIONS ENGINEER INDICATED THAT THE SITE INSISTED ON KEEPING THE STABILIZER BAR, THAT THE SITE RETRAINED THEIR TECHNICIANS IN SAFETY PROCEDURES AND TO FOLLOW THE OPERATOR'S MANUAL INSTRUCTIONS FOR THE STABILIZER BAR. FMSU WAS UNABLE TO CONFIRM ANY OTHER DETAILS REGARDING THE ALLEGED INCIDENT, OR OF THE TECHNICIAN'S ALLEGED INJURY OR TREATMENT. THE SITE ALLOWED THE SERVICE PERSON TO MAKE A BRIEF EXAMINATION OF THE STABILIZER BAR. THE SERVICE PERSON CONCLUDED THE MECHANISM WAS IN GOOD OPERATIONAL ORDER AND UNDAMAGED. FUJIFILM ATTRIBUTES THE CAUSE OF THIS INCIDENT TO OPERATOR ERROR IN NOT ADEQUATELY LOCKING THE STABILIZER BAR IN PLACE. USE OF THE STABILIZER BAR IS DESCRIBED IN THE BUCKY WALL STAND OPERATOR'S MANUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85091 D-EVO SUITE II STATIONARY X-RAY SYSTEM KPR FUJIFILM MEDICAL SYSTEMS U.S.A., INC. BWS TL CM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other