BEUDAMED
    FDA Adverse Event Summary report: N

    BRILLIANCE CT 16-SLICE (AIR)

    MDR report key: 3201142 · Received June 28, 2013

    Report

    Report Number
    1525965-2013-00186
    Date Received
    June 28, 2013
    Report Date
    June 3, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K012009
    Removal / Correction Number
    1525965-06/29/2012-013-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    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

    PHILIPS RECEIVED INFORMATION FROM A CUSTOMER SITE THAT DURING THE IMPLEMENTATION OF (B)(4) (J-BRACKETS BOLTS REPLACEMENT), THE PHILIPS FIELD SERVICE ENGINEER (FSE) FOUND 1 OF THE 16 J-BRACKET BOLTS HAD THE HEAD BROKEN OFF. THERE WAS NO REPORT OF HARM TO A PATIENT OR OPERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295467 BRILLIANCE CT 16-SLICE (AIR) JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728246

    Patients

    Seq Age Sex Outcome Treatment
    1