BEUDAMED
    FDA Adverse Event Other Summary report: N

    FORTE GAMMA SYSTEM

    MDR report key: 3487519 · Received November 8, 2013

    Report

    Report Number
    1525965-2013-00386
    Event Type
    Other
    Date Received
    November 8, 2013
    Report Date
    May 4, 2007
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    KPS
    PMA / PMN Number
    K982911
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED AS A RESULT OF A RETROSPECTIVE REVIEW OF PHILIPS HEALTHCARE COMPLAINTS BACK TO (B)(4) OF 2007. PHILIPS REVIEWED THE INFO PROVIDED BY THE CUSTOMER SITE AND FOUND THAT THE FIELD SERVICE ENGINEER (FSE) FSE WHO INITIALLY RESPONDED TO THE CALL WAS NOT TRAINED ON THE FORTE SYSTEM AND DID NOT KNOWN THAT A COR CALIBRATION/CHECK HAD TO BE PERFORMED. ADDITIONALLY, THE REPORTING PHYSICIAN WHO READ THE SCANS WAS A RADIOLOGIST AND NOT A NUCLEAR MEDICINE PHYSICIAN. THE PRESENCE OF DEFECTS IN THE SAME AREA OF THE MYOCARDIUM FOR SEVERAL PTS SHOULD HAVE ALERTED THE PHYSICIAN. NO ADDITIONAL PT INFO WAS PROVIDED BY THE CUSTOMER SITE. PRODUCT DOCUMENTATION INCLUDING SERVICE MANUAL AND USER'S MANUAL ADDRESS COR CALIBRATION AND COR CHECK. PHILIP'S POLICY FOR CUSTOMER SERVICE PROPRIETARY, CONFIDENTIAL MATERIALS AND SERVICES FOR PMS EQUIPMENT ((B)(4))STATES THAT AN FSE MUST BE PROPERLY TRAINED TO PERFORM SERVICE ON PMS EQUIPMENT. THEREFORE, UNTRAINED FSE SHOULD NOT PERFORM SERVICE WITHOUT SUPERVISION. (B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED INFO FROM A CUSTOMER SITE THAT FOLLOWING SERVICING AND RECALIBRATING OF THE FORTE GAMMA CAMERA, A CENTER OF ROTATION (COR) CALIBRATION WAS RUN BY THE SITE TECHNOLOGIST, AND FOUND TO NOT BE WITHIN SPECIFICATIONS. THE CUSTOMER ALLEGED THAT THE INCORRECT COR CORRECTION HAD BEEN APPLIED TO 10 PT'S STUDIES. OF THE 10 PTS, THE CUSTOMER ALLEGED THAT 4 OF THE 10 PTS MAY HAVE RECEIVED WRONGFUL, ADDITIONAL PROCEDURES AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578493 FORTE GAMMA SYSTEM KPS PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 2155-3000B

    Patients

    Seq Age Sex Outcome Treatment
    1