BEUDAMED
    FDA Adverse Event Other Summary report: N

    AXIS

    MDR report key: 3432712 · Received September 30, 2013

    Report

    Report Number
    1525965-2013-00309
    Event Type
    Other
    Date Received
    September 30, 2013
    Report Date
    January 19, 2007
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    KPS
    PMA / PMN Number
    K9642712
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED AS A RESULT OF A RETROSPECTIVE REVIEW OF PHILIPS HEALTHCARE COMPLAINTS BACK TO JANUARY OF 2007. PHILIPS FIELD SERVICE ENGINEER (FSE) EVALUATED THE SYSTEM AND DETERMINED THAT THE PROBLEM WAS CAUSED BY UNTRAINED PERSONNEL ATTEMPTING TO PERFORM A COLLIMATOR EXCHANGE. THIS SYSTEM HAS BEEN SERVICED BY A THIRD PARTY PROVIDER FOR SEVERAL YEARS; IMPROPER TRAINING COULD CAUSE THIS DAMAGE BY INSERTING A COLLIMATOR SERVER WITH COLLIMATORS ON THE SERVER AND THE ON THE DETECTOR. THE COLLIMATOR ON THE DETECTOR WOULD COLLIDE WITH THE COLLIMATOR ON THE SERVER CAUSING THE DAMAGE. FURTHERMORE, DOCUMENT # (B)(4) ARE AXIS/IRIX HEAD BUCKET FATIGUE TEST REPORTS INDICATING THAT THE TOTAL DEFLECTION FROM THE LEAD BUCKET TO THE MOUNTING PLATE AFTER CONTINUOUS ROTATION WITH THE SUPPLEMENTAL WEIGHT TO REPRESENT A REAL SITUATION OF A 35-YEAR LIFE CYCLE. THE TOTAL DEFLECTION THAT WAS CALCULATED AFTER THE TEST WAS .080" FROM THE LEAD BUCKET TO THE MOUNTING PLATE, WHICH WAS LESS THAN THE MEASURED .1875" ON THE SYSTEM IN THE REPORTED EVENT. THE LEAD BUCKET WAS REPLACED AT THE CUSTOMER SITE AND THE SYSTEM IS OPERATING AS INTENDED. (B)(4). FINAL MDR MAILED ON SEPTEMBER 30, 2013.

    Description of Event or Problem · 1

    PHILIPS RECEIVED INFO FROM A CUSTOMER SITE THAT THE DETECTOR ONE LEAD BUCKET OF THE AXIS SPECT SYSTEM STARTED SEPARATING FROM ITS MOUNTING PLATE. THERE WAS NO REPORT OF INJURY TO PT OR OPERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492171 AXIS KPS PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 882130

    Patients

    Seq Age Sex Outcome Treatment
    1