BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 1950318 · Received December 14, 2010

    Report

    Report Number
    1518293-2010-00166
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER TROUBLESHOT AND FOUND LOOSE CONNECTORS. FSE RESEATED CONNECTIONS AND VERIFIED PROPER FILAMENT RESISTANCE AND PROPER OPERATION USING HUT DR SERVICE MANUAL (B)(4), SEDECAL GENERATOR SERVICE MANUAL (B)(4), HUESTIS COLLIMATOR SERVICE MANUAL (B)(4), AND INFIMED PLATINUM ONE TECH MANUAL (B)(4). UNIT PASSED CHECKOUT PROCEDURES AND WAS RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THEY LOST FLUORO DURING PROCEDURE. HOWEVER, STAFF WERE ABLE TO COMPLETE DIGITAL SPOTS. CUSTOMER REPORTS PHYSICIAN COMPLETED THE PROCEDURE USING DIGITAL SPOTS IMAGES. CUSTOMER PROVIDED NO PT OR PROCEDURAL INFO OTHER THAN PROCEDURE COMPLETED; 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