BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2021894 · Received February 25, 2011

    Report

    Report Number
    1720753-2011-01693
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 25, 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 CAMERA WAS REPLACED AND CALIBRATED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, THE SYSTEM STOPPED AND IMAGES WERE NOT VISIBLE DURING FLUOROSCOPY XRAY. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC XRAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1