BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-CAM COINCIDENCE MODE [510 (K) K970627)

    MDR report key: 328742 · Received April 20, 2001

    Report

    Report Number
    1423253-2001-00005
    Event Type
    Malfunction
    Date Received
    April 20, 2001
    Date of Event
    April 9, 2001
    Report Date
    April 9, 2001
    Manufacturer
    SIEMENS MEDICAL SYSTEMS, INC., NMG GROUP
    Product Code
    IYX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A DEVICE MALFUNCTION WAS IDENTIFIED. UNDER SPECIFFIC CONDITIONS ICON SOFTWARE WILL RESULT IN INCORRECT ORIENTATION OF ACQUIRED PATIENT DATA IN "SPECT" MODE. THIS OCCURS WHEN SWITCHING FROM "COINCIDENCE" MODE TO "SPECT" MODE ON THE ECAM VIA THE PATIENT POSITIONING MONITOR (PPM). WHILE AT THE SAME TIME THERE IS AN ICON PLANAR ACQUISITION SELECTED. THE INCORRECT ORIENTATION MAY CAUSE THE DISPLAYED IMAGE TO BE REVERSED IN EITHER "LEFT TO RIGHT OR "TOP TO BOTTOM" DIRECTIONS. IT MAY NOT BE IMMEDIATELY CLEAR TO THE USER THAT THE IMAGE HAS BEEN REVERSED. A POTENTIAL FOR MISDIAGNOSIS EXISTS AT THAT POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18330 E-CAM COINCIDENCE MODE [510 (K) K970627) GAMMA CAMERA IYX SIEMENS MEDICAL SYSTEMS, INC., NMG GROUP K970627 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA