BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRILLIANCE BIG BORE ONCOLOGY

    MDR report key: 5055509 · Received September 4, 2015

    Report

    Report Number
    1525965-2015-00238
    Event Type
    Malfunction
    Date Received
    September 4, 2015
    Report Date
    August 7, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    JAK
    PMA / PMN Number
    K033357
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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

    THE CUSTOMER REPORTED THAT A STABILIZATION BAR SHEARED OFF THE HEAD OF THE EXACT THERAPY TOP. THE PHILIPS CALL CENTER CONFIRMED THAT THERE WAS NO HARM TO A PATIENT, OPERATOR OR BYSTANDER. A PHILIPS FIELD SERVICE ENGINEER (FSE) REPORTED THAT THE OPERATOR HAD LOWERED THE EXACT THERAPY TOP, THAT WAS MOUNTED TO THE PATIENT SUPPORT, DOWN ONTO A GURNEY AND THAT THE SCREWS THAT SECURED THE HOOK TO THE EXACT THERAPY TOP PULLED OUT WHICH RESULTED IN THE EXACT THERAPY TOP NOT BEING SECURED TO THE PATIENT SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590301 BRILLIANCE BIG BORE ONCOLOGY COMPUTED TOMOGRAPHY X-RAY JAK PHILIPS MEDICAL SYSTEMS 728243

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown