BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISM NUCLEAR GAMMA CAMERA SYSTEM

    MDR report key: 3030808 · Received March 27, 2013

    Report

    Report Number
    1525965-2013-00070
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Report Date
    March 1, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    KPS
    PMA / PMN Number
    K945261
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PHILIPS RECEIVED A REPORT FROM A CUSTOMER SITE THAT THE OPERATOR WAS PERFORMING A WHOLE BODY SCAN ON A PATIENT. THE GANTRY WAS MOVING LINEARLY AT A CONSTANT SPEED WHEN, UNEXPECTEDLY, THE GANTRY MOTION INCREASED IN SPEED. THE OPERATOR HAD PRESSED AN E-STOP TO HALF GANTRY MOTION AND REMOVED THE PATIENT FROM THE TABLE. AFTER THE PATIENT WAS REMOVED, THE OPERATOR PERFORMED A PREPROGRAMMED MOTION FOR THE PATIENT LOAD POSITION. THE GANTRY HAD LOST ITS POSITION AND RAN INTO THE HEAD END PEDESTAL, WHICH CAUSED A COLLISION TO OCCUR. THE OPERATOR POWERED DOWN THE SYSTEM AND CALLED PHILIPS SERVICE FOR SUPPORT. THERE WAS NO INJURY TO PATIENT OR OPERATOR. THERE WAS NO RESCAN THAT OCCURRED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125289 PRISM NUCLEAR GAMMA CAMERA SYSTEM KPS PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. N210819

    Patients

    Seq Age Sex Outcome Treatment
    1