BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUOROSCOPIC X-RAY

    MDR report key: 2760120 · Received August 14, 2007

    Report

    Report Number
    1720753-2007-25981
    Event Type
    Malfunction
    Date Received
    August 14, 2007
    Date of Event
    June 25, 2007
    Report Date
    August 14, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE MALFUNCTION WAS VERIFIED. IDENTIFIED THE NEED TO REPLACE THE BATTERIES. FACILITY STATED THAT THEY WILL ORDER BATTERIES AND REPLACE. THEY WILL FINISH THE REPAIR. NO ADDITIONAL INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9800 SYSTEM WOULD BOOT, BUT AN ERROR MESSAGE OF PRECHARGE FAIL WOULD BE DISPLAYED. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. 9800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK