BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X3C 2200 WITH MAGELLAN 3.4 SOFTWARE INSATLLED

    MDR report key: 1470095 · Received July 30, 2009

    Report

    Report Number
    9616853-2009-00001
    Event Type
    Malfunction
    Date Received
    July 30, 2009
    Date of Event
    July 2, 2009
    Report Date
    July 27, 2009
    Manufacturer
    IMAGING DYNAMICS COMPANY (IDC)
    Product Code
    KPR
    PMA / PMN Number
    K071401
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AN IMAGING DYNAMICS COMPANY (IDC) X3C 2200 DIGITAL RADIOGRAPHIC SYSTEM WAS IN USE AT (B)(6). AT APPROX 9:00 PM AN IMAGE OF THE PT TAKEN BY THE RADIOLOGY TECHNICIAN APPEARED ON THE SYSTEM PREVIEW SCREEN, BUT SUBSEQUENTLY DID NOT APPEAR IN THE STUDY ON THE IDC UNIT. THE SUBJECT REQUIRED AN ADDITIONAL EXPOSURE TO COMPENSATE FOR THE MISSING IMAGE. UPON FURTHER INVESTIGATION, IT WAS DETERMINED THE COMPUTER WAS NOT CONFIGURED AS REQUIRED BY ICD, AND A LACK OF ADEQUATE AVAILABLE COMPUTER MEMORY CAUSED A LONG IMAGE PROCESSING TIME TO OCCUR. DURING THE INITIAL IMAGE PROCESSING, THE RADIOLOGY TECHNICIAN ATTEMPTED TO TAKE ANOTHER EXPOSURE CAUSING THE INITIAL IMAGE TO BE LOST. THERE WAS NO INJURY TO ANY HEALTH PROFESSIONAL. THERE WAS NO ACCIDENTAL RADIATION EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X3C 2200 WITH MAGELLAN 3.4 SOFTWARE INSATLLED DIGITAL X-RAY IMAGING SYSTEM KPR IMAGING DYNAMICS COMPANY (IDC) X3C 2200 (M3. 4)

    Patients

    Seq Age Sex Outcome Treatment
    1