BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KING HME BOOSTER

    MDR report key: 797029 · Received December 15, 2006

    Report

    Report Number
    797029
    Event Type
    Injury
    Date Received
    December 15, 2006
    Date of Event
    December 13, 2006
    Report Date
    December 15, 2006
    Manufacturer
    KING SYSTEMS CORP
    Product Code
    BTT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT FOUND WITH 2-3 INCH BURN TO LEFT DELTOID AREA. VENTILATOR HEAT SENSOR (BOOSTER) VERY HOT TO TOUCH, NOTED TO BE TOUCHING DELTOID AREA WHEN BURN FOUND. THE PT SUFFERED 3RD DEGREE BURN. WILL POSSIBLY REQUIRE EXCISION AND SKIN GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KING HME BOOSTER HUMIDITY BOOSTER BTT KING SYSTEMS CORP 0344 *

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention| S VENTILATOR-840 NELLCOR PURITAN BENETT