BEUDAMED
    FDA Adverse Event Summary report: N

    BRIGHTVIEW XCT IMAGING SYSTEM

    MDR report key: 3738495 · Received March 21, 2014

    Report

    Report Number
    1525965-2014-00059
    Date Received
    March 21, 2014
    Report Date
    February 22, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    KPS
    PMA / PMN Number
    K080927
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE WILL FILE A F/U MDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    IN THIS CASE, THE OPERATOR TRIED TO PLACE FLAT PANEL DISPLAY (FPD) INTO THE DEPLOY POSITION BUT COULD NOT LOCK IN INTO PLACE. A PHILIPS SERVICE ENGINEER EVALUATED AND FOUND THE STEEL WIRE AND METALLIC ROD LOCATED ON THE FPD ARM HAD FAILED CAUSING THE PIN NOT TO EXTRUDE FOR LOCKING THE FPD INTO THE DEPLOY POSITION ON THE SYSTEM. THE PHILIPS SERVICE ENGINEER ALLEGES THAT A MISALIGNMENT INSIDE THE ARM OF THE FPD HAD CAUSED THE REPORTED EVENT ON THE SYSTEM. THE FPD HAS BEEN PROPERLY PLACED AND LOCKED IN THE STOWED POSITION IN ORDER FOR THE OPERATOR TO USE THE SYSTEM FOR SPECT IMAGING PRIOR TO PROPER REPAIRS BEING MADE TO THE SYSTEM. THE PHILIPS SERVICE ENGINEER MADE REPAIRS TO THE FPD SO IT CAN BE PLACED IN THE DEPLOY POSITION FOR THE SYSTEM. THERE WAS NO HARM TO A PATIENT OR OPERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170669 BRIGHTVIEW XCT IMAGING SYSTEM KPS PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 882482

    Patients

    Seq Age Sex Outcome Treatment
    1