BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 1232516 · Received November 13, 2008

    Report

    Report Number
    1720753-2008-28060
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Date of Event
    October 16, 2008
    Report Date
    November 13, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS RELATED TO GE HEALTHCARE COMPLAINT NUMBER. THE GE SERVICE REP SPOKE WITH THE CUSTOMER AND CONFIRMED THE PROBLEM REPORTED. HE CHECKED SYSTEM AND WAS UNABLE TO DUPLICATE THE PROBLEM REPORTED. THE REP FOUND THE POWER CORD PLUG CONNECTION WERE LOOSE AND TIGHTEN CONNECTION ON THE POWER PLUG. HE CHECKED OPERATION AND FOUND THAT THE MACHINE WORKS AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE IMAGES HAVE LINES THROUGH THE CENTER AND THE SYSTEM INTERMITTENTLY TURNS OFF. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1