BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 1360482 · Received March 25, 2009

    Report

    Report Number
    1518293-2009-00081
    Event Type
    Malfunction
    Date Received
    March 25, 2009
    Date of Event
    March 2, 2009
    Report Date
    March 2, 2009
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER TROUBLESHOT PROBLEM FINDING ONLY ONE CONSOLE FAN OPERATING AND NOTING THE TOP OF THE GENERATOR WAS HOT. FSE REPLACED THE FAILED FAN ASSEMBLY CHECKED AND VERIFIED PROPER OPERATION. SYSTEM RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THE CONSOLE LOST COMMUNICATION WITH THE GENERATOR; NO FLUORO AVAILABLE. NO REPORTED INJURY TO THE PATIENT.

    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