BEUDAMED
    FDA Adverse Event Other Summary report: N

    EMERSON

    MDR report key: 545549 · Received September 17, 2004

    Report

    Report Number
    1216146-2004-00002
    Event Type
    Other
    Date Received
    September 17, 2004
    Date of Event
    October 17, 2003
    Report Date
    August 18, 2004
    Manufacturer
    J. H. EMERSON CO.
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS DECIDED AT A FOLLOW-UP MEETING TO THIS EVENT TO SUBMIT A VOLUNTARY MEDWATCH REPORT. MODERATE BURNS WERE CAUSED BY A HEAT THERAPY LAMP DETERMINED TO BE TOO CLOSE TO THE PT. WHEN THE LAMP WAS EXAMINED AT THE TIME OF THE INCIDENT, IT WAS DISCOVERED THAT THE SLEEVE CAP SURROUNDING THE HEIGHT ADJUSTMENT SLIDE HAD BROKEN OFF AND WAS MISSING. THIS ALLOWS FREE PLAY WHICH COULD HAVE ALLOWED THE LAMP TO SLIDE DOWN TO THE LEVEL WHERE THE SAFETY PIN WAS ENGAGED. (2-4 IN. ). IT WAS UNDETERMINED IF THIS WAS A CONTRIBUTING FACTOR IN THIS INCIDENT, HOWEVER USERS SHOULD BE WARNED TO MONITOR CORRECT DISTANCE (28") BETWEEN LAMP AND PT. ALSO, SLEEVE CAPS WHICH PREVENT HEIGHT ADJUSTMENT FREEPLAY SHOULD BE EXAMINED FOR CRACKS DURING ROUTINE SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMERSON WARMING LIGHT FMT J. H. EMERSON CO. 96-TDL *

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Other