BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 4192538 · Received October 22, 2014

    Report

    Report Number
    1518293-2014-00133
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 6, 2014
    Manufacturer
    LIEBEL FLARSHEIM
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER(FSE) FOUND THE FLUORO DOSE WAS READING 10.2 R /MIN ADULT AND 4.66 R/MIN CHILD. E17 WAS ORIGINALLY SET AT 145 AND ADJUSTED E17 TO 143. THE NEW FLUORO ADULT DOSE READING WAS AT 9.3 R/MIN AFTER CALIBRATION. THE 10.2 READING BY FSE ON THIS INVESTIGATION BEING BARELY ABOVE 10R SUGGESTS THE DIFFERENCE FROM PREVIOUSLY SET VALUE, IS WITHIN THE TOLERANCE OF THE METERS USED WHICH ARE +/- 5%. FSE PERFORMED SYSTEM CHECK USING SERVICE CHECKLIST, AND RETURNED UNIT TO FULL SERVICE.

    Description of Event or Problem · 1

    FACILITY BIOMED REPORTS DOSE RATE NEEDS ADJUSTED, GOING OVER 10R/MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672811 HUT EXT DR FINAL ASSY-REVERSE IXR IXR LIEBEL FLARSHEIM

    Patients

    Seq Age Sex Outcome Treatment
    1