BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUNNELL LIFEPULSE HIGH FREQUENCY VENTILATOR

    MDR report key: 10374902 · Received August 6, 2020

    Report

    Report Number
    1719232-2020-00002
    Event Type
    Malfunction
    Date Received
    August 6, 2020
    Date of Event
    January 21, 2020
    Report Date
    August 3, 2020
    Manufacturer
    BUNNELL, INC.
    Product Code
    LSZ
    PMA / PMN Number
    P850064
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS INITIALLY REPORTED IN (B)(6) 2020. AN INVESTIGATION WAS COMPLETED AND CONCLUDED THAT: "THE REPORTED SYMPTOM THAT THE VENT SHUT DOWN COULD BE VERIFIED. OPERATION IN THE HFV READY CONDITION WAS VERY STABLE WITH MINIMUM FLUCTUATIONS, HOWEVER DUE TO DIRTY/FOWLED WAFER TERMINALS ON THE P1 CONNECTOR OF THE VALVE DRIVE REGULATOR CCA, A VENT FAULT 10 AND VENTILATOR FAULT ALARMS COULD BE MADE TO BE GENERATED WHEN THE VDR CAA WAS WIGGLED. THE WAFER TERMINALS OF THE CONNECTOR WERE CLEANED WITH ISOPROPYL ALCOHOL WHICH CORRECTED THE CONDITION AND RESTORED NORMAL OPERATION. NO PROBLEMS WERE FOUND WITH THE HFV POWER SUPPLY AND DISTRIBUTION SYSTEMS AND ALL DISTRIBUTED VOLTAGE WERE VERIFIED TO BE WELL WITHIN SYSTEMS SPECIFICATIONS. THE SYSTEM WAS VERIFIED TO BE IN NEAR PERFECT CALIBRATION CONDITION AND ALL CONTROL AND MONITORING CIRCUITRY WAS VERIFIED TO RESPONDED CORRECTLY TO ALL INPUT VARIATIONS. THE HFV WAS THOROUGHLY INSPECTED AND TESTED WITH NO ADDITIONAL PROBLEMS FOUND. HFV 2641 WAS FULLY SERVICED AND PASSED ALL APPLICABLE TESTING REQUIREMENTS." GIVEN THAT ALL APPROPRIATE ALARM SYSTEMS AND OTHER SAFETY MEASURES WERE IN PLACE AND FUNCTIONING APPROPRIATELY TO PREVENT PATIENT INJURY, IT WAS DETERMINED, AT THAT TIME, THAT THIS EVENT WAS NOT REPORTABLE. THIS MDR IS BEING FILED IN RESPONSE TO A REQUEST RECEIVED FROM THE FDA FOR ADDITIONAL INFORMATION RELATED TO USER FACILITY REPORT (B)(4).

    Description of Event or Problem · 1

    AS REPORTED IN USER FACILITY REPORT (B)(4): "PATIENT WAS DESATTING AND THE VENTILATOR WAS ON, BUT I DIDN'T HEAR THE SCISSOR VALVE FIRING AND NOTICED THAT THE JET PEAK INSPIRATORY PRESSURE (PIP) WAS SET AT 20 WHEN IT WAS SUPPOSED TO BE AT 40. I THEN REMOVED THE BABY FROM THE VENTILATOR AND STARTED NEOPUFFING DUE TO DROPPING SATS. MY COWORKERS AND I TRIED TO RECALIBRATE THE JET, AND IT STOPPED IN THE MIDDLE AND TURNED OFF. WE THEN TRIED AGAIN, AND IT STOPPED AFTER 3 SECONDS. WE THEN DECIDED TO PULL IN A NEW JET AND SWITCH VENTILATORS. UNIT WAS A BUNNELL RENTAL JET VENTILATOR, UNIT WAS RETURNED TO BUNNELL. NO FURTHER ACTION REQUIRED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839185 BUNNELL LIFEPULSE HIGH FREQUENCY VENTILATOR BUNNELL LIFEPULSE JET VENTILATOR LSZ BUNNELL, INC. 203

    Patients

    Seq Age Sex Outcome Treatment
    1