BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 1130393 · Received August 20, 2008

    Report

    Report Number
    1518293-2008-00252
    Event Type
    Malfunction
    Date Received
    August 20, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 22, 2008
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING INVESTIGATION PENDING. UPON COMPLETION OF THE INVESTIGATION, A MEDWATCH SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS FOLLOWING AN ELECTRICAL STORM, THE NEXT MORNING DURING A PROCEDURE, THE PHYSICIAN COULD NOT GET A "MAG" VIEW AND COULD NOT PERFORM RAD SHOTS. THE CUSTOMER REBOOTED THE ROOM AND THE GENERATOR WOULD NOT COME UP. PROCEDURE COMPLETED WITH USE OF A C-ARM PORTABLE FLUORO. POTENTIAL FOR SERIOUS INJURY EXISTS.

    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