BEUDAMED
    FDA Adverse Event Other Summary report: N

    (BASIC) SYSTEM CT 9000

    MDR report key: 1053292 · Received May 16, 2008

    Report

    Report Number
    1518293-2008-00112
    Event Type
    Other
    Date Received
    May 16, 2008
    Report Date
    March 17, 2006
    Manufacturer
    LIEBEL-FLARSHEIM CO
    Product Code
    IZQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPLACED J-BOW AND CLEANED CONSOLE SCREEN AND RETURNED TO SERVICE. WE ARE WRITING IN REFERENCE TO THE INCIDENT WHICH OCCURRED AT THE MEDICAL CENTER. WE HAVE EVALUATED THE PHOTOGRAPHS ATTACHED TO YOUR E-MAIL DATE MARCH 24, 2006, AND ARE ABLE TO MAKE THE FOLLOWING COMMENTS. THE DAMAGE SHOWN DID NOT OCCUR FROM NORMAL OR REASONABLE USE. THERE IS A CLEAR INDICATION OF FRETTING WHICH IS THE RESULT OF CONTINUED RUBBING OF LOOSE PARTS. THE FINAL SEPARATION OF THE PIECES OCCURRED LONG AFTER THERE WAS OBVIOUS DAMAGE AND NEED FOR REPAIR OR REPLACEMENT OF THE UNIT. WE HOPE OUR COMMENTS ARE OF HELP TO YOU.

    Description of Event or Problem · 1

    LF QUALITY REPORTED VIA FAX THAT GE CONTACTED TYCO WITH REPORT OF CEILING MOUNT FAILURE. INFORMATION PROVIDED VERY LIMITED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 (BASIC) SYSTEM CT 9000 CT POWER INJECTOR IZQ LIEBEL-FLARSHEIM CO CT9000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK