BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKYLIGHT IMAGING SYSTEM

    MDR report key: 2013652 · Received February 4, 2011

    Report

    Report Number
    2916556-2011-00001
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Report Date
    January 13, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    KPS
    Removal / Correction Number
    2916556-12/28/2010-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION BY PHILIPS ENGINEERING FOUND THAT THREE SUBJECT CAMERA SYSTEMS FAILED WITH SIMILAR MODES AND EFFECTS. THE FAILURE MODE IS THE CRACKED LOWER ARM CASTING AT THE UPPER "EAR" SECTION. THIS FAILURE RESULTS IN DOWNWARD DISPLACEMENT OF THE ARM AND DETECTOR DUE TO GRAVITY. THE EXACT CAUSE OF FAILURE OF THIS SPECIFIC CAMERA SYSTEM WAS NOT DETERMINED BECAUSE THE ARM WAS NOT MADE AVAILABLE FOR ANALYSIS DURING THIS PERIOD OF TIME. NO SPECULATION IS PROVIDED FOR CAUSE OF THIS FAILURE. ADDITIONAL FAILURE ANALYSES WERE CONDUCTED ON TWO OF THE PREVIOUSLY RETURNED SUBJECT CAMERA'S ARM WITH CAUSES OF LOWER ARM CRACKS ATTRIBUTED TO ONE OR MORE OF THE FOLLOWING: MATERIAL PROPERTIES NOT MEETING SPECIFICATION. MISALIGNMENT OF THE TWO (2) LINEAR BEARING RAILS AND THE INABILITY OF THE FULLY COMPRESSED BELLEVILLE WASHERS TO DISPLACE ENOUGH LOAD TO LIMIT EAR SECTION BENDING. OPERATOR MISUSE RESULTING IN ARM COLLISION WITH STATIC OBJECT SUCH AS THE PATIENT TABLE RESULTING IN OVERLOADING OF THE LOWER ARM CASTING. THE AMOUNT OF PRELOAD APPLIED BY THE BELLEVILLE WASHERS CAN CAUSE BENDING STRESSES IN THE EAR SECTIONS. THE AMOUNT OF PRELOAD VARIES WITH PART TOLERANCES AND BEARING RAIL MISALIGNMENT. ALL POTENTIALLY AFFECTED SKYLIGHT AND PRECEDENCE SYSTEMS WILL BE INSPECTED AND CORRECTED VIA C&R 2916556-12/28/2010-002-C. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER SITE HAS REPORTED THAT SYSTEM IS SUSPECTED TO HAVE A CRACK IN THE DETECTOR ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKYLIGHT IMAGING SYSTEM GAMMA CAMERA SYSTEMS KPS PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 2160-300B

    Patients

    Seq Age Sex Outcome Treatment
    1