BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-STANDARD

    MDR report key: 5107600 · Received September 28, 2015

    Report

    Report Number
    1518293-2015-00091
    Event Type
    Malfunction
    Date Received
    September 28, 2015
    Date of Event
    August 31, 2015
    Report Date
    February 26, 2016
    Manufacturer
    LIEBEL FLARSHEIM
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION. UPON RECEIPT OF INVESTIGATION, A MEDWATCH 3500A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTED THAT THE PHYSICIST FAILED THE PATIENT DOSE DISPLAY DURING THE INSPECTION, REPORTING THAT IT WAS NOT DISPLAYING WITHIN THE 35% ACCURACY REQUIRED UNDER THE 1020CFR. FIELD SERVICE ENGINEER (FSE) WENT ON SITE AND REVIEWED THE PHYSICIST REPORT WHICH SHOWED THE FLUORO DOSE MEASURED WAS 16.5 R/MIN. FSE CHECKED THE FLUORO MAXIMUM DOSE WITH UNFORS METER (B)(4) AND NOTED THE MAXIMUM DOSE WAS 17.8 R/MIN. FSE ADJUSTED THE ADULT FLUORO MAXIMUM DOSE OF 9.44 R/MIN. THEN CHECKED THE CHILD DOSE WHICH WAS 6 R/MIN. AND ADJUSTED THIS TO YIELD A CHILD MAXIMUM FLUORO DOSE OF 4.59 R/MIN. FSE COMPLETED THE PATIENT DOSE DISPLAY CALIBRATION AND TESTED THE SYSTEM USING CHECKLIST QSSRWI4.1 AND RETURNED THE UNIT TO THE CUSTOMER FOR SERVICE. IT WAS DETERMINED TO HAVE FSE RE-MEASURE THE DOSAGES ON AN ADDITIONAL SERVICE VISIT, (B)(4), WHERE FSE MEASURED DOSE FOR ADULT AT 9.5 R/MIN., AND CHILD AT 4.6 R/MIN. TO MAKE SURE THERE WAS NO CHANGES IN DOSAGE, FSE WAS SCHEDULED TO RETURNED TO FACILITY ON SERVICE (B)(4), WHERE THE FSE AGAIN MEASURED DOSAGE AND REPORTED ADULT = 9.5 R/MIN CHILD = 4.6 R/MIN. THESE DOSE VALUES REPORTED ON THESE TWO ADDITIONAL CHECKS, WERE ESSENTIALLY THE SAME AS SET BY FSE ON THE INITIAL VISIT AFTER PHYSICIST REPORT. IT IS UNKNOWN WHY THE DOSE LEVELS WERE HIGH WHEN THE PHYSICIST DID THE CHECK.

    Description of Event or Problem · 1

    A PHYSICIST FOUND THE SYSTEM IS SHOOTING 180% HIGHER THAN SELECTED KV. NOTE: THIS IS NOT THE DOSE OF THE SYSTEM. FSE REPORTS:THE PHYSICIST REPORT SHOWED THE FLUORO DOSE MEASURED WAS 16.5 R/MIN. I CHECKED THE FLUORO MAXIMUM DOSE WITH UNFORS METER ((B)(4)) AND NOTED THE MAXIMUM DOSE WAS 17.8 R/MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640641 HUT EXT DR FINAL ASSY-STANDARD HUT EXT DR FINAL ASSY-STANDARD IXR LIEBEL FLARSHEIM HUT EXT DR FINAL ASSY-STANDARD

    Patients

    Seq Age Sex Outcome Treatment
    1