BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOVENT 4000CPAP W/ALARM

    MDR report key: 2480383 · Received February 28, 2012

    Report

    Report Number
    1924066-2012-00003
    Event Type
    Malfunction
    Date Received
    February 28, 2012
    Date of Event
    February 13, 2012
    Report Date
    February 23, 2012
    Manufacturer
    ALLIED HEALTHCARE PRODUCTS, INC.
    Product Code
    BTL
    PMA / PMN Number
    K070636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT WAS RETURNED; (BPM) BREATHES PER MINUTE WERE TESTED ON UNIT. ALLIED COULD NOT DUPLICATE COMPLAINT; RAN UNIT FOR 3 TO 4 HOURS; NO CHANGE IN BPM. IT APPEARS THE PATIENT MAY HAVE STARTED TO BREATHE SPONTANEOUSLY. IF A PATIENT BEGINS TO BREATHE SPONTANEOUSLY, THE BREATH ASSIST OF THE VENTILATOR WILL ADJUST THE BPM OF THE PATIENT'S BREATH RATE. THE AUTOVENT 4000 OPERATION MANUAL ASSISTS THE USER WHEN THIS SITUATION OCCURS: OPERATING THE AUTOVENT: (VENTILATION). SPONTANEOUS BREATHING BY THE PATIENT: SHOULD THE PATIENT BEGIN TO BREATHE SPONTANEOUSLY THE AUTOVENT 4000CPAP WILL SENSE THIS BREATH AND DELIVER THE SET TIDAL VOLUME AT THE SET INSPIRATORY RATE. THE BREATH TIMING WILL BE RESET BASED ON THE SELECTED BPM RATE. FOR EXAMPLE, IF 10 BPM WAS SELECTED THE NEXT BREATH WILL BE DELIVERED 6 SECONDS AFTER THE START OF THE SPONTANEOUS BREATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PARAMEDIC HAD A PATIENT EN ROUTE ON AN HOUR LONG TRANSPORT USING AN AUTOVENT. THE UNIT WAS SET FOR 12 BPM BUT STARTED GIVING BREATHES AT ABOUT 24 BPM. IT SEEMED TO THE PARAMEDIC THE UNIT WAS JUST BLOWING NON-STOP. HE UNPLUGGED THE UNIT TRYING TO RESET IT; PLUGGED IT BACK IN; UNIT WORKED FOR ABOUT 30 SECONDS. AS A RESULT THE PARAMEDIC HAD TO MANUALLY BAG THE PATIENT FOR MOST OF THE TRANSPORT. THIS MADE IT DIFFICULT TO CONTROL DOPHAMEAN AND RESUSCITATE AT THE SAME TIME. AS A RESULT THE PATIENT'S BLOOD PRESSURE SHIFTED FROM HIGH TO LOW. NO INFORMATION WAS GIVEN ON END RESULT OF PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOVENT 4000CPAP W/ALARM VENTILATOR BTL ALLIED HEALTHCARE PRODUCTS, INC. L763CPAP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other