BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 2240877 · Received August 16, 2011

    Report

    Report Number
    1518293-2011-00140
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Report Date
    July 21, 2011
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER TROUBLESHOT AND FOUND THE SEDECAL GENERATOR X-RAY CONSOLE WAS LOCKING UP AND REPLACED THE GENERATOR CONSOLE AND THE FIRMWARE. FSE THEN VERIFIED PROPER OPERATION USING HUT DR SERVICE MANUAL, SEDECAL GENERATOR SERVICE MANUAL, HUESTIS COLLIMATOR SERVICE MANUAL, AND THE INFIMED PLATINUM ONE TECH MANUAL. UNIT PASSED CHECKOUT PROCEDURES AND WAS RETURNED TO FULL SERVICE.

    Description of Event or Problem · 1

    ON (B)(6): CUSTOMER REPORTED SYSTEM DID NOT FLUORO DURING THREE SEPARATE PT PROCEDURES ALL OCCURRING DURING THE LAST THREE WEEKS. THIS RECORD DOCUMENTS INCIDENT NUMBER 3. PT AND PROCEDURAL INFO WAS NOT MADE AVAILABLE BY THE CUSTOMER. PROCEDURE WAS COMPLETED BY MOVING PT INTO AN OPERATING ROOM AND USING A PORTABLE FLUORO C-ARM. PT WAS FINE. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUT EXT DR FINAL ASSY-REVERSE UROLOGY SYSTEM KQS LIEBEL-FLARSHEIM CO. HUT EXT DR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK