BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-STANDARD

    MDR report key: 2040325 · Received February 15, 2011

    Report

    Report Number
    1518293-2011-00045
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER TROUBLESHOT AND REPLACED THE BLOWN IN LINE 50 AMP FUSES. THESE FUSES PROTECT THE GENERATOR FROM LINE CURRENT FLUCTUATIONS. FSE TESTED AND VERIFIED PROPER OPERATION PER SERVICE CHECKLIST QSSRWI4.1 AND SYSTEM RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    ON (B)(6): CUSTOMER REPORTED THE UROLOGY SYSTEM FAILED AT THE START OF THE DAY. FACILITY DOES NOT HAVE A BACK-UP ROOM FOR PROCEDURES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA