BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISION R-FD FLAT PANEL DIGITAL MOBILE C-ARM

    MDR report key: 5986603 · Received September 27, 2016

    Report

    Report Number
    MW5065085
    Event Type
    Malfunction
    Date Received
    September 27, 2016
    Date of Event
    July 20, 2015
    Report Date
    September 27, 2016
    Manufacturer
    ZIEHM IMAGING INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ACQUIRED X-RAY IMAGES DISPLAY SIDEWAYS. THIS HAS BEEN REPORTED TO THE MFR (ZIEHM IMAGING, INC.) AS OF (B)(6) 2015 AND THERE HAS BEEN NO CLINICALLY VIABLE PERMANENT SOLUTION TO ADDRESS THIS PROBLEM. FROM CLINICAL PERSPECTIVE, THIS CAN BE PT SAFETY ISSUE AS IMAGES ARE MISLABELED AND CAN BE MISINTERPRETED. WE HAVE SAMPLES OF IMAGES THAT HAVE BEEN SENT TO THE MFR WITH NO RESPONSE ON WHEN THIS WILL BE FIXED. INSTEAD WORKAROUNDS WERE PROPOSED RATHER THAN SOLVING THE UNDERLYING PRODUCT PROBLEM. THESE WORKAROUNDS TAKE MORE TIME THAN IS NECESSARY AND PROLONG THE PT'S MEDICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632708 VISION R-FD FLAT PANEL DIGITAL MOBILE C-ARM DIGITAL MOBILE C-RAM JAA ZIEHM IMAGING INC. VISION R-FD FLAT PANEL DIGITAL M

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other