BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRISM 2000 GAMMA CAMERA

    MDR report key: 1002924 · Received February 8, 2008

    Report

    Report Number
    1525965-2008-00006
    Event Type
    Other
    Date Received
    February 8, 2008
    Report Date
    February 8, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    IYX
    PMA / PMN Number
    K904050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL INVESTIGATION DETERMINED THE FOLLOWING: THE COLLIMATOR ID BOARD ON HEAD 2 WAS SHIMMED OUT. AS A RESULT, THE DETECTOR FALSELY SENSED THE COLLIMATOR WAS LATCHED. THE BLOCK ON THE ID BOARD WAS DAMAGED. IT WAS DETERMINED THAT THE SYSTEM WAS UNDER THIRD PARTY SERVICE. THE LAST PREVENTIVE MAINTENANCE WAS CONDUCTED IN 2006. ENGINEERING REVIEW OF THE PHOTS TAKEN AT THE SITE DETERMINED THAT FURTHER INVESTIGATION AT THE SITE WAS NECESSARY. DURING A SITE VISIT, A PHILIPS TECHNICAL SUPPORT ENGINEER OBSERVED THE FOLLOWING: THE GANTRY COVERS WERE MISSING SEVERAL CLIPS. THIS PREVENTS A SECURE ATTACHMENT OF THE FRONT AND REAR COVER. THERE IS A COLLECTION OF METAL SHAVINGS ON THE DETECTOR. THIS WAS MOST LIKELY THE RESULT OF THE RUBBER CUSHION ON THE DETECTOR BEING VERY WORN. WHEN THE DETECTOR IS ROTATED, THE SHAVINGS COULD FALL IN THE PT'S EYES. THE COLLIMATOR SERVER CART HAD BEEN MODIFIED BY REMOVING THE TOP SAFETY CATCHES (INTENDED TO PREVENT THE COLLIMATOR FROM FALLING DURING EXCHANGE). THE WRAP AROUND THE GANTRY POWER CABLES WAS SPLIT. ALL THE CABLES INSIDE WERE IN GOOD CONDITION AND NONE OF THE INSULATION WAS DAMAGED. THE MOST PROBABLE ROOT CAUSE OF THESE ISSUES IS IMPROPER MAINTENANCE PERFORMED BY THE CUSTOMER. THERE WAS NO SERIOUS INJURY TO PT OR OPERATOR.

    Description of Event or Problem · 1

    TECHNICIAN WAS LOADING THE MEGAP-PAR (MEDIUM ENERGY ALL PURPOSE-PARALLEL) COLLIMATOR ON TO DETECTOR HEAD 2 FOR A NEW PT SCAN. MEGAP-PAR COLLIMATOR SEPARATED FROM THE DETECTOR HEAD SHORTLY AFTER LOADING. THE COLLIMATOR WAS HELD TO THE HEAD BY SAFETY LATCH. NO INJURY TO PT OR OPERATOR OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISM 2000 GAMMA CAMERA GAMMA CAMERA IYX PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 4535 665 12911

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK