BEUDAMED
    FDA Adverse Event Other Summary report: N

    MX 8000 IDT 16

    MDR report key: 1744622 · Received June 25, 2010

    Report

    Report Number
    1525965-2010-00011
    Event Type
    Other
    Date Received
    June 25, 2010
    Date of Event
    May 17, 2010
    Report Date
    May 18, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K012009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS MAILED ON (B)(4) 2010.

    Description of Event or Problem · 1

    A SOFTWARE UPGRADE WAS INSTALLED ON A CUSTOMER'S SCANNER. WHEN THE SOFTWARE UPGRADE IS COMPLETED, THE SITE SPECIFIC PROTOCOLS MUST BE MANUALLY ADJUSTED BY THE USER. THE SITE SPECIFIC PROTOCOL WILL BECOME INOPERABLE (WARNING MESSAGE DISPLAYED) UNTIL THE USER HAS ADJUSTED OR ACCEPTED THE PROTOCOLS. THE CUSTOMER IS INSTRUCTED IN THE INSTRUCTIONS FOR USE AND INSTALLATION INSTRUCTIONS TO CONTACT A PHILIPS REPRESENTATIVE TO OBTAIN ASSISTANCE IN CREATING THE SITE SPECIFIC PROTOCOLS. THE CUSTOMER ELECTED TO ADJUST THE PROTOCOLS AND ACCEPT THEM WITHOUT CONTACTING PHILIPS. WHEN THE CUSTOMER ACCEPTED THE PROTOCOL, THE INCREMENT WAS NOT APPROPRIATELY SET TO COINCIDE WITH THE COLLIMATION WIDTH. THIS DIFFERENCE CAUSED THE SCAN TO CONTINUOUSLY SKIP 3 MM OF THE BRAIN DURING A SCAN WHICH COULD POTENTIALLY LEAD TO A MISSED DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MX 8000 IDT 16 JAK/CT JAK PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 728120

    Patients

    Seq Age Sex Outcome Treatment
    1