BEUDAMED
    FDA Adverse Event Death Summary report: N

    BUNNELL LIFEPULSE HIGH FREQUENCY VENTILATOR

    MDR report key: 22921585 · Received August 29, 2025

    Report

    Report Number
    1719232-2025-00003
    Event Type
    Death
    Date Received
    August 29, 2025
    Date of Event
    July 28, 2025
    Report Date
    October 6, 2025
    Manufacturer
    BUNNELL, INC.
    Product Code
    LSZ
    PMA / PMN Number
    P850064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE RETURNED FOR INVESTIGATION ON 08/12/2025. THIS INVESTIGATION IS ONGOING. THE REPORTED SYMPTOM THAT THE PEEP COULD NOT BE CHANGED HAS NOT BEEN REPRODUCED. PRELIMINARY INVESTIGATION RESULTS: THE HFV PASSED THE SELF TEST AND THE OPERATIONAL VERIFICATION REQUIREMENTS WHERE OPERATION WAS VERY STABLE WITH MINIMUM FLUCTUATIONS OF THE MONITORED DISPLAYED VALUES AND WITH NO SYSTEM ALARMS OF ANY TYPE GENERATED IN THE HFV READY CONDITION. THE PIP ALWAYS ACHIEVED THE SET POINT AND THE RESULTANT MAP AND PEEP REMAINED EXTREMELY STABLE WITH MINIMAL FLUCTUATIONS. AT THIS THIS POINT IN TIME THE INVESTIGATION IS STILL ONGOING. THE USER FACILITY DID NOT RETURN THE ADAPTER FOR INVESTIGATION. THE EVENT DESCRIPTION FROM THE USER FACILITY DOES NOT CLEARLY INDICATE IF THIS IS A BUNNELL LIFEPORT ADAPTER OR OTHER ETT ADAPTER (WHICH IS NOT MANUFACTURED BY BUNNELL). MULTIPLE ATTEMPTS HAVE BEEN MADE, VIA PHONE AND E-MAIL, TO OBTAIN ADDITIONAL INFORMATION FROM THE USER FACILITY. NO ADDITIONAL INFORMATION HAS BEEN MADE AVAILABLE. THE USER FACILITY INDICATED ISSUES SETTING PEEP AND BUR. IT IS NOTED THAT THE LIFEPULSE DOES NOT HAVE SETTINGS FOR PEEP OR BUR. A FOLLOW-UP REPORT WILL BE SUBMITTED FOLLOWING COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    DEVICE RETURNED FOR INVESTIGATION ON 08/12/2025. INITIAL REPORT SUBMITTED 08/27/2025 WHILE THE INVESTIGATION WAS ONGOING. THIS REPORT BEING SUBMITTED TO FOLLOW-UP WITH INVESTIGATION RESULTS. THE REPORTED SYMPTOM THAT THE PEEP COULD NOT BE CHANGED WAS NOT REPRODUCED. THE REPORTED SYMPTOM COULD NOT BE VERIFIED AND WAS NOT REPRODUCED AS REPORTED. HOWEVER, AFTER THREE DAYS OF OPERATION, THE SERVO PRESSURE DISPLAY DROPPED TO 0.0 PSI. THIS WAS A MINOR DISPLAY ISSUE AND THE HFV SYSTEM CONTINUED TO FUNCTION NORMALLY. THE PIP ALWAYS ACHIEVED THE SET POINT WITH MINIMAL OVER AND UNDERSHOOT, AND THE RESULTANT MAP AND PEEP REMAINED EXTREMELY STABLE WITH MINIMAL FLUCTUATIONS. A TERMINAL CONNECTOR WAS FOUND TO HAVE DIRTY/FOULED CONNECTOR TERMINALS THAT SUPPLY THE VOLTAGE AND SIGNALS FROM THE SERVO PRESSURE TRANSDUCER WHICH CAUSED THE SERVO PRESSURE DISPLAY TO DROP TO 0.0 PSI. ALL WAFER TERMINALS ASSOCIATED WITH THIS DISPLAYED VALUE WERE REPLACED, WHICH CORRECTED THE CONDITION. THE HFV AND PB WERE THOROUGHLY INSPECTED, TESTED, AND OPERATIONALLY VERIFIED TO HAVE NO ADDITIONAL PROBLEMS. THE SYSTEM STABILIZED AT THE DEFAULT CONTROLS SETTINGS WITH ALL MONITORED VALUES REMAINING VERY STABLE WITH VERY LITTLE FLUCTUATIONS. THE HFV FI SUBJECT UNIT AND THE PB FI SUBJECT UNIT WERE FULLY SERVICED AND PASSED ALL APPLICABLE TESTING REQUIREMENTS. THE USER FACILITY DID NOT RETURN THE ADAPTER FOR INVESTIGATION. THE EVENT DESCRIPTION FROM THE USER FACILITY DOES NOT CLEARLY INDICATE IF THIS IS A BUNNELL LIFEPORT ADAPTER OR OTHER ETT ADAPTER (WHICH IS NOT MANUFACTURED BY BUNNELL). MULTIPLE ATTEMPTS HAVE BEEN MADE, VIA PHONE AND E-MAIL, TO OBTAIN ADDITIONAL INFORMATION FROM THE USER FACILITY. NO ADDITIONAL INFORMATION HAS BEEN MADE AVAILABLE. THE USER FACILITY INDICATED ISSUES SETTING PEEP AND BUR. IT IS NOTED THAT THE LIFEPULSE DOES NOT HAVE SETTINGS FOR PEEP OR BUR. THEREFORE, IT IS LIKELY THE USER FACILITY ERRONEOUSLY ASSOCIATED AN ISSUE WITH A DEVICE MANUFACTURED BY A DIFFERENT MANUFACTURER WITH THE BUNNELL HFV SYSTEM IN QUESTION. THE MINOR DISPLAY ISSUE OBSERVED DOES NOT PRESENT PATIENT RISK AS THE DEVICE CONTINUED TO FUNCTION NORMALLY, PER THE INPUT SETTINGS. IT HAS BEEN CONCLUDED THIS EVENT IS NOT A REPORTABLE IN REGARDS TO THE BUNNELL HFV SYSTEM.

    Description of Event or Problem · 0

    THE USER FACILITY INDICATED THEY WERE TRYING TO ADJUST THE PEEP BUT WERE UNABLE TO. THE USER FACILITY BIOMEDICAL GROUP REPORTED: "A NOTE WITH THE DEVICE INDICATED "PEEP SET AT +6 ALL DAY, WENT TO INCREASE TO +7 AND WOULD NOT INCREASE. BUR WAS SET TO 0. WHEN BUR TURNED ON TO 1, PEEP WAS READING 3. CHECK THE ADAPTER AND COULD NOT FIND A LEAK." HOWEVER, THE WORK ORDER THAT WAS CALLED IN STATED THAT THEY WERE NOT ABLE TO ADJUST THE PEEP, LEAK IN THE ADAPTER. THEY DIDN'T INDICATE IF THERE WAS AN ERROR CODE OR NOT, AND THERE WAS A REPORTED PATIENT DEATH."

    Description of Event or Problem · 0

    THE USER FACILITY INDICATED THEY WERE TRYING TO ADJUST THE PEEP BUT WERE UNABLE TO. THE USER FACILITY BIOMEDICAL GROUP REPORTED: "A NOTE WITH THE DEVICE INDICATED "PEEP SET AT +6 ALL DAY, WENT TO INCREASE TO +7 AND WOULD NOT INCREASE. BUR WAS SET TO 0. WHEN BUR TURNED ON TO 1, PEEP WAS READING 3. CHECK THE ADAPTER AND COULD NOT FIND A LEAK." HOWEVER, THE WORK ORDER THAT WAS CALLED IN STATED THAT THEY WERE NOT ABLE TO ADJUST THE PEEP, LEAK IN THE ADAPTER. THEY DIDN'T INDICATE IF THERE WAS AN ERROR CODE OR NOT, AND THERE WAS A REPORTED PATIENT DEATH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2213648 BUNNELL LIFEPULSE HIGH FREQUENCY VENTILATOR VENTILATOR, HIGH FREQUENCY LSZ BUNNELL, INC. 203

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death