BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY - STANDARD

    MDR report key: 1361252 · Received January 30, 2009

    Report

    Report Number
    1518293-2009-00002
    Event Type
    Malfunction
    Date Received
    January 30, 2009
    Date of Event
    January 6, 2009
    Report Date
    January 6, 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

    FIELD SERVICE ENGINEER TROUBLESHOT SYSTEM AND FOUND THE RIBBON CABLE IN THE X-RAY CONSOLE WHICH CONNECTS TO THE DISPLAY WAS NOT SEATED PROPERLY. FSE RESEATED THE CONNECTOR AND VERIFIED PROPER OPERATION PER THE SEDECAL GENERATOR SERVICE MANUAL 710953. SYSTEM RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    ON 01/06: CUSTOMER REPORTS SYSTEM WOULD NOT POWER UP AT ALL. CUSTOMER HAS NO OTHER ROOMS AVAILABLE FOR PROCEDURES.

    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