BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY - STANDARD

    MDR report key: 1881177 · Received October 5, 2010

    Report

    Report Number
    1518293-2010-00134
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 17, 2010
    Manufacturer
    LIEBEL-FLARSHEIM CO
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER CONFIRMED DOSAGE OVER 10R/M AND ADJUSTED FLUORO OUTPUT FROM 10.3R/M TO 9.0R/M. A REVIEW LAST SERVICE RECORD, FROM MAY 2010 SHOWS THE DOSAGE WAS CHECKED BY FSE AND FOUND TO BE UNDER 10R/M. A REVIEW OF CTS SHOWS NO OTHER DOSAGE ISSUES REPORTED. UNIT WAS RETURNED TO FULL SERVICE BY THE CUSTOMER. NO FURTHER INVESTIGATION NEEDED AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTS, DURING ANNUAL PHYSICIST REVIEW OF THE TABLE, DOSE RATE WAS FOUND TO BE 10.3R/M.

    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