BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HME BOOSTER

    MDR report key: 823152 · Received March 2, 2007

    Report

    Report Number
    1824226-2007-00001
    Event Type
    Injury
    Date Received
    March 2, 2007
    Date of Event
    January 25, 2007
    Report Date
    February 6, 2007
    Manufacturer
    KING SYSTEMS CORP.
    Product Code
    BTT
    PMA / PMN Number
    K990614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: KING SYSTEMS AND MEDISIZES HAVE DETERMINED THAT THIS TYPE OF EVENT CAN HAPPEN IF WATER LEAKS INTO THE BACKSIDE OF THE HEATER ELEMENT. THIS LEAKAGE CAN OCCUR IF THE USER DOES NOT FOLLOW THE INSTRUCTIONS FOR USE, WHICH IS INCLUDED WITH THE DEVICE. SPECIALLY: TURN OFF THE WATER FEED SET BEFORE REMOVING THE HEATING ELEMENT FROM THE T-PIECE. ALWAYS USE THE FLOW REGULATOR TO LIMIT THE WATER AVAILABLE TO 10 ML PER HOUR. WHEN IN USE, POSITION THE HEATER CORD BELOW THE HORIZONTAL PLANE. POSITION THE WATER FEED SET SO THAT THE LINE DOES NOT CROSS THE ELECTRICAL COMPONENTS. CHECK IF THE O-RING ON THE HEATER IS IN GOOD CONDITION. NEVER IMMERSE THE HME-BOOSTER HEATER IN LIQUID.

    Description of Event or Problem · 1

    THE USER-FACILITIE REPORTED: PT HAS RECEIVED A BURN ON HIS LEFT FOREARM WE THINK THE BURN CAME FROM A FAULTY HME BOOSTER THAT WAS INLINE WITH HIS VENTILATOR CIRCUIT. PT HAD BLISTERS ON HIS LEFT FOREARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HME BOOSTER HEATER BTT KING SYSTEMS CORP. MSB-600 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention