BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 2022220 · Received February 28, 2011

    Report

    Report Number
    1720753-2011-01710
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 28, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE REPLACEMENT PARTS HAVE BEEN ORDERED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE 9600 SYSTEM FAILED TO PRODUCE FLUOROSCOPY X-RAY. NO REPORT OF PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1