BEUDAMED
    FDA Adverse Event Summary report: N

    BRILLANCE 64

    MDR report key: 2842494 · Received November 13, 2012

    Report

    Report Number
    1525965-2012-00097
    Date Received
    November 13, 2012
    Report Date
    October 15, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY WERE HAVING TABLE MOVEMENT ISSUES. ON (B)(6)-2012, THE PHILIPS FIELD SERVICE ENGINEER (FSE) DETERMINED FROM THE SYSTEM LOGS, THAT THE UNLOAD BUTTON ON THE LEFT GANTRY CONTROL PANEL HAD STUCK ENGAGED. THIS OCCURRED WHILE THE SYSTEM WAS NOT IN USE. IF THIS MALFUNCTION WERE TO RECUR DURING A PT PROCEDURE, THERE IS POTENTIAL FOR PINCHING, ENTRAPMENT AND REMOVAL OF PATIENT MEDICAL TUBING (I.E. VENTILATOR TUBING, IV TUBING, ETC.) AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRILLANCE 64 JAK PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 425231

    Patients

    Seq Age Sex Outcome Treatment
    1