BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1232588 · Received November 13, 2008

    Report

    Report Number
    1720753-2008-27983
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Date of Event
    October 22, 2008
    Report Date
    November 12, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 REPLACED THE FRICTION ROLLER AND HIGH VOLTAGE CABLES. THE SYSTEM IS WORKING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN THE C IS ROTATED A SCREECHING NOISE IS HEARD. THE PLASTIC COVERING ON THE HIGH VOLTAGE CABLE IS CRACKED. NO INJURIES WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1