BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUNNELL

    MDR report key: 4177394 · Received September 12, 2014

    Report

    Report Number
    1719232-2014-00005
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 11, 2014
    Manufacturer
    BUNNELL, INC.
    Product Code
    LSZ
    PMA / PMN Number
    P850064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED SYMPTOM GIVING A VENT FAULT 03 ERROR CODE COULD BE VERIFIED AND WAS REPRODUCED EXACTLY AS REPORTED. ADDITIONALLY A JET VALVE FAULT, VENTILATOR FAULT AND A LOSS OF PIP ALARM WERE GENERATED ALMOST IMMEDIATELY DURING THE OPERATIONAL VERIFICATION TESTING. A MICROCIRCUIT COMPONENT ON THE HFV PROCESSOR CCA (OR GATE U30), WHICH CONTROLS THE OPERATION OF THE PWM VALVES, PURGE VALVE, SOLENOID AND DUMP VALVE, HAD FAILED. THE MICROCIRCUIT WAS REPLACED AND THE HFV WAS THOROUGHLY INSPECTED, TESTED, AND FUNCTIONALLY VERIFIED TO HAVE NO OTHER PROBLEMS. NO ADDITIONAL DISCREPANCIES WERE FOUND. THIS WAS THE FIRST CONFIRMED FAILURE OF THIS COMPONENT IN THE HISTORY OF THE HFV DEVICE.

    Description of Event or Problem · 1

    RECEIVED CALL FROM (B)(6) (RT) SAYING THAT "JET HAD SHUT DOWN AND FAILED ON A PATIENT". THEY SWITCHED OUT THE JET FOR A DIFFERENT UNIT TO SUPPORT THE PATIENT. THEY TESTED THE "FAILED" JET AN IT RESULTED IN A VENT FAULT 03 A FEW TIMES BEFORE HE CALLED. HE DID SAY, PATIENT DECOMPENSATED AFTER THE JET SHUT OFF (DECOMPENSATION AND DESATURATION TO 70). PATIENT RECOVERED AND WAS STABILIZED AND TRANSITIONED TO ANOTHER JET. NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565204 BUNNELL LIFE PULSE HFV LSZ BUNNELL, INC. 203

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention