BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 1396857 · Received March 12, 2009

    Report

    Report Number
    1518293-2009-00050
    Event Type
    Malfunction
    Date Received
    March 12, 2009
    Date of Event
    February 12, 2009
    Report Date
    February 12, 2009
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON 2/19: CUSTOMER REPORTS (B) (6) MALE HAVING A LASER LITHOTRIPSY UNDER GENERAL ANESTHESIA WHEN FLUORO FAILED. CUSTOMER BROUGHT PORTABLE C-ARM FLUORO INTO ROOM AND COMPLETED PROCEDURE. NO REPORTED PATIENT 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 76 YR