BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-TWO SYSTEMS E SERIES E-700 TRANPORT VENT

    MDR report key: 8233980 · Received January 10, 2019

    Report

    Report Number
    MW5083031
    Event Type
    Malfunction
    Date Received
    January 10, 2019
    Date of Event
    January 8, 2019
    Report Date
    January 9, 2019
    Manufacturer
    O-TWO MEDICAL TECHNOLOGIES, INC.
    Product Code
    BTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WAS USING TRANSPORT VENTILATOR FOR PRE PURCHASE EVALUATION. WE WERE DOING A FACILITY TRANSFER FOR A VENT DEPENDENT PT. DURING THE TRANSPORT, THE VENTILATOR CAUGHT ON FIRE. THE PT WAS IMMEDIATELY DISCONNECTED FROM THE DEVICE AND DID NOT HAVE ANY INJURY OR ADVERSE REACTION FROM THE EVENT. SETTINGS WAS MODE ASSIST / CONTOL, RATE 16, TIDAL VOLUME 400, PEEP OF 5, FIO2 60% AND ONE TIME 1:2. THE PT WAS MOVED OVER TO AMBULANCE STRETCHER AND REMOVED FROM BED SIDE VENT. THE PT WAS PLACED ON O-TWO TRANSPORT VENT AND VENT WAS CONNECTED TO PORTABLE OXYGEN TANK USING SUPPLY LINE. THE PT WAS PLACED ON END TIDAL CO2 WITH DIGITAL READING 42 CMH2O WITH GOOD WAVE FORM PRESENT, SPO2 94% WITH NO NOTED VENT ALARMS. PT WAS MOVED TO MEDIC 23 AND STRETCHER SECURED IN. THE TRANSPORT VENT OXYGEN SUPPLY LINE WAS DISCONNECTED FROM PORTABLE OXYGEN BOTTLE AND HOOKED UP TO AMBULANCE MAIN SUPPLY TANK. NOTED THE VENT WAS BLINKING A LOW BATTERY LIGHT, THE VENT CHARGER WAS ATTACHED TO VENT. MEDIC 23 TRANSPORTED AT 1733 HOURS. PARAMEDIC (B)(6) SEATED IN CAPTAIN SEAT MONITORING PT AND VENT DURING TRANSPORT WITH NO NOTED ALARMS AT APPROXIMATE TIME 1756 HOURS, PARAMEDIC (B)(6) NOTED SMOKE COMING FROM VENT CHARGING PORT, AT THIS TIME THERE WAS A LOUD POPPING NOISE AND PARAMEDIC (B)(6) SEEN BRIGHT YELLOW FLAMES COMING FROM VENT, FLAMES WAS NOTED TO BE ABOUT 6 INCHES IN HEIGHT. PARAMEDIC (B)(6) IMMEDIATELY REMOVED PT FROM VENT CIRCUIT AND DISCONNECTED THE OXYGEN SUPPLY LINE TO VENT FROM THE AMBULANCE OXYGEN OUTLET. PARAMEDIC (B)(6) THREW A BLANKET OVER THE VENT TO SMOTHER THE FLAMES OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28369 O-TWO SYSTEMS E SERIES E-700 TRANPORT VENT VENTILATOR, EMERGENCY, POWERED BTL O-TWO MEDICAL TECHNOLOGIES, INC. E-700 TRANSPORT

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR