BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 2020414 · Received February 8, 2011

    Report

    Report Number
    1518293-2011-00013
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 14, 2011
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER TROUBLESHOT AND DIAGNOSED THE HARD DRIVE TO BE BAD. FSE REPLACED THE SYSTEM'S HARD DRIVE AND CD DRIVE PER INFIMED SERVICE MANUAL. FSE COMPLETED THE OPERATIONAL CHECK OF THE SYSTEM PER SERVICE CHECKLIST AND UNIT RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    ON (B)(6): CUSTOMER REPORTS MALE UNDERGOING A UROLOGY PROCEDURE FOR STENT PLACEMENT WHEN FLUORO FAILED. PHYSICIAN COMPLETED THE PROCEDURE WITH USE OF ENDOSCOPE. NO FURTHER INCIDENT, NO REPORTED 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 UNK