BEUDAMED
    FDA Adverse Event Summary report: N

    BRILIANCE BIG BORE

    MDR report key: 3010211 · Received March 14, 2013

    Report

    Report Number
    1525965-2013-00049
    Date Received
    March 14, 2013
    Report Date
    February 19, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033357
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. INTERNAL CROSS REFERENCE: (B)(4).

    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. INTERNAL CROSS REFERENCE: (B)(4).

    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. INTERNAL CROSS REFERENCE: (B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED INFORMATION THAT THE CUSTOMER REPORTED THE GANTRY WOULD INTERMITTENTLY NOT BOOT UP AND LISTED AN ERROR DESCRIBING A STUCK BUTTON. THE FIELD SAFETY ENGINEER ARRIVED ON SITE AND THE CUSTOMER HAD RESOLVED THE ISSUE ON THEIR OWN. THERE WAS NO REPORT OF OPERATOR OR PATIENT INVOLVEMENT DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108287 BRILIANCE BIG BORE JAK PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 728244

    Patients

    Seq Age Sex Outcome Treatment
    1