BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-STANDARD

    MDR report key: 1915301 · Received November 2, 2010

    Report

    Report Number
    1518293-2010-00147
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 8, 2010
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER FOUND AND REPLACED A BAD FOOTSWITCH WITH DAMAGED CORD. FSE VERIFIED PROPER OPERATION PER SERVICE CHECKLIST. SYSTEM RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    ON (B)(6): CUSTOMER REPORTS DURING STENT PLACEMENT PROCEDURE, THE SYSTEM FLUORO FAILED. PHYSICIAN COMPLETED PROCEDURE UTILIZING ENDOSCOPY. CUSTOMER REPORTS PROCEDURE COMPLETED WITHOUT FURTHER INCIDENT AND PT IS FINE. NO REPORTED INJURY.

    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