BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OHMEDA

    MDR report key: 1052881 · Received May 28, 2008

    Report

    Report Number
    MW5007043
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    May 22, 2008
    Report Date
    May 28, 2008
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    HUMIDIFIER ON UNIT HAD BLACK SOOT AND BURNT SMELL COMING FROM IT. UPON INSPECTION WE FOUND THAT THE INSULATION MATERIAL WAS BREAKING DOWN CAUSING THE UNIT TO EMIT A BURNING SMELL AND POSSIBLE FIRE HAZARD. OHMEDA IS AWARE OF THE PROBLEM AND ISSUED A DESIGN CHANGE FOR 2006, BUT NEVER SENT OUT REPLACEMENTS TO THE FACILITIES THAT HAD THE OLDER DESIGN (PRE 2006) FOR UPGRADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OHMEDA WARMER, RADIANT, INFANT, MOBILE FMT OHMEDA MEDICAL 4400

    Patients

    Seq Age Sex Outcome Treatment
    1