BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-STANDARD

    MDR report key: 2153483 · Received June 21, 2011

    Report

    Report Number
    1518293-2011-00107
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION. UPON RECEIPT OF INVESTIGATION, A MEDWATCH 3500A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6): CUSTOMER REPORTS STAFF ATTEMPTING TO PERFORM AN UNDETERMINED UROLOGY PROCEDURE WHEN FLUORO MONITORS FAILED. PATIENT AND PROCEDURE INFORMATION NOT PROVIDED BY THE CUSTOMER. STAFF COMPLETED THE PROCEDURE BY USING THE CONTROL ROOM FLUORO MONITOR TO THE SIDE. NO REPORTED INJURY.

    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 UNK