BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1133696 · Received August 20, 2008

    Report

    Report Number
    1720753-2008-24881
    Event Type
    Malfunction
    Date Received
    August 20, 2008
    Date of Event
    August 11, 2008
    Report Date
    August 20, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEM INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A CASE, THE IMAGE WENT FROM NORMAL TO ALL SNOWY AND THEY COULD NOT DETERMINE WHAT WAS ON THE IMAGE. CUSTOMER REPORTED NO PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1