BEUDAMED
    FDA Adverse Event Summary report: N

    SKYLIGHT IMAGING SYSTEM

    MDR report key: 2222698 · Received July 8, 2011

    Report

    Report Number
    2916556-2011-00026
    Date Received
    July 8, 2011
    Report Date
    June 15, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    KPS
    PMA / PMN Number
    K000908
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT. WE WILL FILE A FOLLOW-UP MDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE HEAD 2 OF SKYLIGHT GAMMA CAMERA WAS MOVING VERTICALLY DOWNWARDS AND HIT A BOX UNDER IT. COLLISION SENSORS EVENTUALLY STOPPED THE MOVEMENT. HEAD 2 WAS THEN MANUALLY MOVED UP AND THE BOX WAS REMOVED. THEN AFTER, THE CAMERA WAS SET TO PARK, BUT HEAD 2 FELL DOWN TO THE BOTTOM (LOWEST POSITION OF HEAD 2) WITH A LOUD NOISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKYLIGHT IMAGING SYSTEM KPS PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 2160-3000A

    Patients

    Seq Age Sex Outcome Treatment
    1