BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICON

    MDR report key: 200863 · Received December 2, 1998

    Report

    Report Number
    1423253-1998-00007
    Event Type
    Malfunction
    Date Received
    December 2, 1998
    Date of Event
    November 10, 1998
    Report Date
    November 10, 1998
    Manufacturer
    SIEMENS MEDICAL SYSTEMS, INC., NMG GROUP
    Product Code
    JWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN AUTOPERFUSION PROGRAM, LOAD A GATED STRESS AND NON-GATED REST STUDY. IF SAVE OBLIQUES OPTION IS USED WHEN THE GATED DATA IS DISPLAYED THE SAVED NON-GATED REST FILE DOES NOT CONTAIN THE REST DATA OF TIME BIN FOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICON COMPUTER JWM SIEMENS MEDICAL SYSTEMS, INC., NMG GROUP NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other