BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 2022902 · Received February 24, 2011

    Report

    Report Number
    1720753-2011-01633
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 31, 2011
    Report Date
    February 24, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE REP PERFORMED AN ON SITE INVESTIGATION. THE SOFTWARE WAS RELOADED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM DISPLAYED A SOFT WARE CORRUPT ERROR CODE. NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9600 FLUOROSCOPIC XRAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1