BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRILLIANCE 40

    MDR report key: 4840281 · Received June 12, 2015

    Report

    Report Number
    1525965-2015-00163
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Report Date
    May 18, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033326
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (EMDR NUMBER 1525965-2015-00163) HAS BEEN DETERMINED TO BE A DUPLICATE OF COMPLAINT (B)(4) (EMDR NUMBER 1525965-2015-00166). THE INVESTIGATION RESULTS FOR COMPLAINT (B)(4) WILL BE DOCUMENTED IN COMPLAINT (B)(4) (EMDR NUMBER 1525965-2015-00166).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IN THIS CASE THE CUSTOMER REPORTED THAT A PATIENT WAS BEING TRANSFERRED FROM A STRETCHER ONTO THE CT BED. BEFORE THE PROCEDURE BEGAN AND BEFORE THE PATIENT WAS DRIVEN INTO THE GANTRY THE BED LOWERED ITSELF SLOWLY TO THE LOWEST POSITION AND THE CUSTOMER WAS NOT ABLE TO DRIVE IT UP. THE PHILIPS FIELD SERVICE ENGINEER (FSE) CONFIRMED THERE WAS NO HARM TO A PATIENT, OPERATOR OR BYSTANDER. THE FSE STATED THAT THE ESTOP DID OPEN BUT THE TABLE HAD MOVED DOWN TO THE HARDWARE LIMIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384892 BRILLIANCE 40 COMPUTED TOMOGRAPHY X-RAY JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728235

    Patients

    Seq Age Sex Outcome Treatment
    1