BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFE2000 VENTILATOR PACKAGED

    MDR report key: 10762280 · Received October 30, 2020

    Report

    Report Number
    3008778542-2020-00002
    Event Type
    Injury
    Date Received
    October 30, 2020
    Date of Event
    October 18, 2020
    Report Date
    October 30, 2020
    Manufacturer
    BREATHE TECHNOLOGIES, INC.
    Product Code
    CBK
    PMA / PMN Number
    K170037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BURNS TO THE FACE ARE GENERALLY CONSIDERED SEVERE. THIRD DEGREE BURNS MAY SWELL, BE PAINLESS, AND HAVE THE APPEARANCE OF DRY LEATHERY OR CHARRED SKIN. THESE BURNS TYPICALLY REQUIRE MEDICAL TREATMENT OF DEBRIDEMENT, OINTMENT, AND POSSIBLY ANTIBIOTICS. THE DEVICE IFU STATES DO NOT ALLOW SMOKING NEAR OXYGEN SOURCES OR NEAR THE VENTILATION SYSTEM AND DO NOT PLACE OXYGEN SOURCES OR THE VENTILATION SYSTEM NEAR ANY SOURCE OF DIRECT HEAT OR OPEN FLAME BECAUSE FLAMMABLE MATERIALS BURN MORE READILY IN THE PRESENCE OF OXYGEN. THE ALLEGATION OF BURN TO THE PATIENTS FACE AND EARS IS A REPORTABLE SERIOUS INJURY DUE TO A USE ERROR OF THE PATIENT SMOKING WHILE USING THE DEVICE. A SEARCH OF THE HILLROM MAINTENANCE RECORDS DID NOT SHOW HILLROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS DEVICE. THERE WAS NO ALLEGED MALFUNCTION OF THE DEVICE. BASED ON THIS INFORMATION, NO FURTHER FOLLOW UP IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THE HOSE CAUGHT FIRE AND WAS BURNED DURING USE OF THE LIFE 2000 DEVICE. FOLLOW UP WITH THE CUSTOMER FOUND THAT CUSTOMER WOKE UP, FORGOT SHE WAS WEARING THE DEVICE, LIT A CIGARETTE, AND THE MASK AND HOSE CAUGHT FIRE AND SHE WAS BURNED ON HER FACE AND EARS. THE CUSTOMER WAS TAKEN TO THE ER WHERE BURNS WERE TREATED WITH OINTMENT, WRAPPED, AND DEBRIDED. THE SEVERITY OF THE CUSTOMER'S BURN ARE NOT KNOWN TO THE CUSTOMER. THE DEVICE WAS LOCATED AT THE PATIENT'S HOME AT THE TIME OF THE EVENTS. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1228669 LIFE2000 VENTILATOR PACKAGED VENTILATOR, CONTINUOUS, FACILITY USE CBK BREATHE TECHNOLOGIES, INC. BT-20-0002

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other