BEUDAMED
    FDA Adverse Event Summary report: N

    BRILLIANCE 6 AIR

    MDR report key: 2861692 · Received November 28, 2012

    Report

    Report Number
    1525965-2012-00109
    Date Received
    November 28, 2012
    Report Date
    October 31, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K012009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AFTER A PATIENT SCAN WAS COMPLETED AND DURING VERTICAL DOWN MOVEMENT OF THE PATIENT TABLE, THE PATIENT TABLE DROPPED APPROXIMATELY 2 INCHES AND THEN STOPPED. THE PATIENT WAS JARRED AND STARTLED, BUT WAS NOT HARMED. THERE IS POTENTIAL FOR SERIOUS INJURY TO A PATIENT OR OPERATOR IF THIS WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRILLIANCE 6 AIR JAK PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 728256

    Patients

    Seq Age Sex Outcome Treatment
    1