BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIRCUIT INFANT HEATED 4FT

    MDR report key: 2767285 · Received January 30, 2008

    Report

    Report Number
    1423507-2008-00011
    Event Type
    Injury
    Date Received
    January 30, 2008
    Date of Event
    December 18, 2007
    Report Date
    January 30, 2008
    Manufacturer
    CARDINAL HEALTH
    Product Code
    BZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    UNFORTUNATELY, THERE IS NO SAMPLE AVAILABLE FOR EVALUATION; THEREFORE WE ARE UNABLE TO CONFIRM THE REPORTED ISSUES. HOWEVER SAMPLES OF THE PROCESS WERE REMOVED AND NO PROBLEMS WERE FOUND RELATED TO ISSUE REPORTED. A LOT NUMBER WAS PROVIDED THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. BASED ON THE LIMITED INFORMATION WE ARE UNABLE TO DETERMINE THE POSSIBLE CAUSE FOR THE REPORTED ISSUE. THE PRODUCT LABEL WARNS THAT OBJECTS SUCH AS HEAVY TAPES, TOWELS, OR BED LINENS MAY OVER INSULATE THE CIRCUITS, IMPEDE NORMAL HEAT CONVECTION, AND CAUSE DAMAGE TO THE TUBING. (B)(4), DATE OF REPORT: (B)(4) 2007, INFO: ALLEGIANCE, LOT # Y06P1456; DEVICE MFR: ALLEGIANCE HEALTHCARE CORP, (B)(4).

    Description of Event or Problem · 1

    PT WAS RECEIVING HUMIDIFIED HEATED OXYGEN BLENDED WITH ROOM AIR VIA NASAL CANNULA. MACHINE "SMELLED" AS THOUGH IT WAS BURNING AND ALARMED "LOW TEMPERATURE". PT WAS REMOVED FROM EQUIPMENT. APPROXIMATELY TWO HOURS LATER BURNS WERE NOTED ON THE PT'S FACE. THE HEATED TUBING CIRCUITRY WAS MELTED AROUND THE HEATED WIRE. THERE WERE NOTABLE BURNS TO THE NOSE. PT WAS INTUBATED AND DURING INTUBATION BURNS WERE ALSO NOTED IN THE TRACHEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIRCUIT INFANT HEATED 4FT CIRCUIT INFANT HEATED 4FT BZO CARDINAL HEALTH 7100-4S2 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 5 DA Hospitalization| L| R| S SUPPLIED BY FISHER & PAYKEL HEALTHCARE| WATER "WELL" LOT # 070906, (B)(4)| HEATED HUMIFICADOR MR 730, (B)(4)