BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUT PATIENT PLUS FLOOR MODEL

    MDR report key: 2308333 · Received September 14, 2011

    Report

    Report Number
    2018492-2011-00006
    Event Type
    Malfunction
    Date Received
    September 14, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    PHILIPS BURTON
    Product Code
    FCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PHILIPS BURTON SUBMITTED AN MDR REPORT FOR THIS INCIDENT ON (B)(6) 2011. HOWEVER THE SUBMISSION WAS FILED ELECTRONICALLY ON FROM 3500. THIS SUBMISSION, ON THE CORRECT FORM 3500A, IS BEING PROVIDED PER FDA REQUEST.

    Description of Event or Problem · 1

    PHILIPS BURTON OUT PT WALL MOUNT MODEL DETACHED AND FELL STRIKING A DOCTOR AND CAUSING A CONCUSSION AND BRUISING. MEDICAL ATTENTION WAS REQUIRED (NO DETAILS WERE PROVIDED). THE LIGHT WAS MANUFACTURED IN (B)(6) 1990'S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OUT PATIENT PLUS FLOOR MODEL AC POWERED MEDICAL EXAMINATION LIGHT FCQ PHILIPS BURTON 010160

    Patients

    Seq Age Sex Outcome Treatment
    1