BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 1003214 · Received February 26, 2008

    Report

    Report Number
    1518293-2008-00014
    Event Type
    Malfunction
    Date Received
    February 26, 2008
    Date of Event
    January 30, 2008
    Report Date
    January 30, 2008
    Manufacturer
    LIEBEL-FLARSHEIM CO
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIEBEL FLARSHEIM FIELD SERVICE REPORT: FIELD SERVICE ENGINEER CHECKED THE DOSE WHEN THEY ARRIVED AND FOUND IT AT 11.2R/MIN. PER SEDECAL SERVICE MANUAL SEC 2.7; FSE PERFORMED A X-RAY TUBE CALIBRATION AND THEN ADJUSTED THE DOSE. AFTER ADJUSTMENT THE ADULT DOSE WAS 9.6R/MIN AND THE CHILD DOSE WAS 4.8R/M IN. UNIT RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT PHYSICIST TESTING INDICATES THAT UROLOGY UNIT EXCEEDS MAXIMUM EXPOSURE RATE OF 10 R/MIN.

    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 DR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other