BEUDAMED
    FDA Adverse Event Other Summary report: N

    EXTENDED BRILLIANCE WORKSTATION (EBW)

    MDR report key: 2992727 · Received March 1, 2013

    Report

    Report Number
    1525965-2013-00020
    Event Type
    Other
    Date Received
    March 1, 2013
    Date of Event
    April 5, 2007
    Report Date
    April 5, 2007
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K961464
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED AS A RESULT OF A RETROSPECTIVE REVIEW OF PHILIPS HEALTHCARE COMPLAINTS BACK TO JANUARY OF 2007. THE PHYSICIAN IN CHARGE OF THE PATIENT'S TREATMENT CONFIRMED THAT THIS ISSUE WAS OPERATOR ERROR AND THE SYSTEM DID NOT MALFUNCTION. AN ANALYSIS OF THE CASE INDICATED NO MISTREATMENT OCCURRED AND THE PATIENT DID NOT SUSTAIN INJURY. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED AS A RESULT OF A RETROSPECTIVE REVIEW OF PHILIPS HEALTHCARE COMPLAINTS BACK TO JANUARY OF 2007. THE PHYSICIAN IN CHARGE OF THE PATIENT'S TREATMENT CONFIRMED THAT THIS ISSUE WAS OPERATOR ERROR AND THE SYSTEM DID NOT MALFUNCTION. AN ANALYSIS OF THE CASE INDICATED NO MISTREATMENT OCCURRED AND THE PATIENT DID NOT SUSTAIN INJURY. (B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED INFORMATION THAT A PATIENT WAS POTENTIALLY MISMARKED FOR A RADIATION THERAPY TREATMENT PLAN. THE PATIENT INVOLVED WAS TREATED WITH A PLAN WITH THE USER IDENTIFYING THE WRONG LOCATION FOR THE TREATMENT BEING SPECIFIED. THE PHYSICIAN IN CHARGE OF THE PATIENT INDICATED THAT THIS TREATMENT DID NOT RESULT IN ANY INJURY TO THE PATIENT OR THE PATIENT REQUIRING FOLLOW-UP TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89844 EXTENDED BRILLIANCE WORKSTATION (EBW) JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728260

    Patients

    Seq Age Sex Outcome Treatment
    1