BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRILLIANE 64

    MDR report key: 4379957 · Received December 30, 2014

    Report

    Report Number
    1525965-2014-00218
    Event Type
    Injury
    Date Received
    December 30, 2014
    Report Date
    December 2, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE WILL FILE A FOLLOW-UP MDR AT THE COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE SYSTEM WAS SITTING OVER NIGHT AND NOT IN CLINICAL USE, FIRE AND SMOKE WERE REPORTED TO BE COMING FROM THE SYSTEM. THE FIELD SERVICE ENGINEER (FSE) REPORTED THAT THE ANODE POWER MODULE (APM) BURNED DURING THE NIGHT WHICH CAUSED A RELEASE OF SMOKE AND A BURNING SMELL. THERE WAS NO REPORT OF HARM TO PATIENT, OPERATOR, OR BYSTANDER DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858169 BRILLIANE 64 COMPUTED TOMOGRAPHY X-RAY JAK PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 728231

    Patients

    Seq Age Sex Outcome Treatment
    1