BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUTIV FINAL ASSY, REV, RIGHT

    MDR report key: 1162332 · Received September 8, 2008

    Report

    Report Number
    1518293-2008-00267
    Event Type
    Malfunction
    Date Received
    September 8, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 8, 2008
    Manufacturer
    LIEBEL-FLARSHEIM CO
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER TROUBLESHOT THE SYSTEM, AND FOUND THAT THE COLLIMATOR WAS TRYING TO DRIVE THE LONG BLADE PAST THE PHYSICAL LIMIT, AND THIS WOULD CAUSE THE UNIT TO ERROR OUT. THE FIELD SERVICE ENGINEER RE-CALIBRATED THE COLLIMATOR PER THE SERVICE MANUAL, RESOLVING THE PROBLEM.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A FEMALE WAS UNDERGOING A URETER KIDNEY STONE REMOVAL, WHEN THE FLUORO SHUT DOWN. SHE REPORTED THAT A PORTABLE C-ARM WAS BROUGHT INTO THE ROOM TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUTIV FINAL ASSY, REV, RIGHT UROLOGY SUITE KQS LIEBEL-FLARSHEIM CO HUTIV NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR