BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 2153484 · Received June 21, 2011

    Report

    Report Number
    1518293-2011-00116
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FSE CONFIRMED BAD DISPLAY ON THE GENERATOR TOUCHSCREEN CONSOLE. FSE REPLACED THE GENERATOR'S TOUCHSCREEN CONSOLE PER SEDECAL MANUAL. FSE COMPLETED THE SERVICE CHECKLIST AND UNIT RETURNED TO SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    ON (B)(6): CUSTOMER REPORTS VIA PHONE THAT DURING ROOM START UP, PRIOR TO PROCEDURES, GENERATOR CONSOLE FAILURE WAS NOTED BY STAFF. CUSTOMER DOES NOT HAVE A BACK UP ROOM FOR PATIENT PROCEDURES. NO REPORTED INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK