BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 1081059 · Received July 21, 2008

    Report

    Report Number
    1518293-2008-00239
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    July 7, 2008
    Report Date
    July 7, 2008
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LIEBEL FLARSHEIM MANUFACTURING REPORT: FIELD SERVICE ENGINEER TROUBLESHOOT PROBLEM TO THE FILAMENT DRIVER PCB. FSE REPLACED THE PCB, VERIFIED SYSTEM OPERATION ACCORDING TO SERVICE MANUAL. ALL SYSTEMS FUNCTIONAL. UNIT RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER REPORTS AT THE BEGINNING OF THE DAY, THE ROOM EXPERIENCED AN ALARM 1, AND FLUORO WAS NOT AVAILABLE. ROOM COULD NOT BE USED. NO PATIENT INJURY EXPERIENCED. THERE IS POTENTIAL FOR INJURY DURING THIS TYPE OF EVENT.

    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