BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 2040318 · Received February 15, 2011

    Report

    Report Number
    1518293-2011-00052
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER WAS CALLED TO CHANGE A 50 AMP FUSE WHICH HAD BLOWN IN THIS UNITS GENERATOR. FSE REPLACED THE FUSE AND VERIFIED PROPER OPERATION PER SERVICE CHECKLIST. UNIT PASSED CHECKOUT PROCEDURES AND WAS RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    (B)(4) 2007: CUSTOMER REPORTS DURING PATIENT PROCEDURE, THE FLUORO FAILED. PATIENT WAS MOVED TO ANOTHER ROOM AND PROCEDURE WAS COMPLETED. PROCEDURE BEING PERFORMED AND PATIENT GENDER/AGE WERE NOT MADE AVAILABLE BY THE CUSTOMER. THERE WAS NO REPORT OF INJURY.

    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