BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICT

    MDR report key: 7511256 · Received May 14, 2018

    Report

    Report Number
    1525965-2018-00398
    Event Type
    Malfunction
    Date Received
    May 14, 2018
    Report Date
    April 16, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K060937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT THE INTERCOM SYSTEM OF THEIR BRILLIANCE ICT SYSTEM WAS NOT WORKING PROPERLY. COMMUNICATION FROM THE CONSOLE TO THE EXAM ROOM CAN BE HEARD BUT NOT THE COMMUNICATION FROM THE EXAM ROOM TO THE CONSOLE. A PHILIPS SENIOR FIELD SPECIALIST (SFS) CONFIRMED THERE WAS NO REPORT OF HARM OR PATIENT IMPACT AS A RESULT OF THIS REPORTED ISSUE. THE SFS CONFIRMED THAT SOUND COULD BE HEARD COMING FROM THE CONSOLE GANTRY AND THAT NO SOUND COULD BE HEARD COMING FROM THE GANTRY TO THE CONSOLE THE SFS DETERMINED FAILING MICROPHONES ON THE FRONT AND REAR BREATHING LIGHT ASSEMBLY WAS THE CAUSE FOR THE OPERATOR'S INABILITY TO HEAR THE PATIENT DURING A PROCEDURE. THE SFS REPLACED THE BREATHING LIGHT ASSEMBLY ON THE FRONT AND REAR OF THE GANTRY TO RESOLVE THIS ISSUE AND THE SYSTEM WAS RETURNED TO FULL FUNCTIONALITY. THE SYSTEM IS IN CLINICAL USE. THIS EVENT HAS BEEN DETERMINED NOT TO BE A REPORTABLE EVENT.

    Additional Manufacturer Narrative · 1

    WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT. WE WILL FILE A FOLLOW-UP EMDR AT THE COMPLETION OF THE INVESTIGATION. INTERNAL CROSS REFERENCE: COMPLAINT PR# (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; THERE IS NO ALLEGATION OF DEATH OR SERIOUS INJURY. THE CUSTOMER REPORTED THAT THE GANTRY MICROPHONE WAS NOT WORKING AND THE PATIENT COULD NOT BE HEARD. IF THE OPERATOR IS UNABLE TO HEAR THE PATIENT DUE TO A FAILED MICROPHONE, THERE IS POTENTIAL FOR INJURY TO THE PATIENT. THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT. THIS EVENT IS CURRENTLY UNDER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352287 ICT SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728306

    Patients

    Seq Age Sex Outcome Treatment
    1