BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUNNELL LIFEPULSE

    MDR report key: 11628163 · Received April 7, 2021

    Report

    Report Number
    1719232-2021-00002
    Event Type
    Malfunction
    Date Received
    April 7, 2021
    Date of Event
    December 21, 2020
    Report Date
    March 10, 2021
    Manufacturer
    BUNNELL, INC.
    Product Code
    LSZ
    PMA / PMN Number
    P850064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED SYMPTOM OF EXCESSIVE MAP COULD NOT BE VERIFIED AND WAS NOT REPRODUCED AS REPORTED. OPERATION WAS VERY STABLE WITH NO ALARMS OF ANY TYPE GENERATED AND NO PROBLEMS OF ANY TYPE WERE FOUND WITH THE HFV DISPLAY. THE PIP ALWAYS ACHIEVED THE SET POINT WITH MINIMUM FLUCTUATIONS AND THE SERVO PRESSURE, MAP AND PEEP WERE ALWAYS VERY STABLE AND WELL WITHIN SYSTEMS SPECIFICATIONS WITH THE PEEP VERIFIED TO BE RESPONSIVE. NO PROBLEMS WERE FOUND WITH THE HFV POWER SYSTEM, PNEUMATIC SYSTEM OR WITH THE HFV PROCESSOR AND DRIVER CCAS. ALL CONTROL AND FEEDBACK SIGNALS WERE VERIFIED TO BE OPERATING CORRECTLY AND RESPONDING ACCURATELY. THE SYSTEM WAS VERIFIED TO BE WELL WITHIN CALIBRATION SPECIFICATIONS. THE HFV WAS THOROUGHLY INSPECTED, TESTED AND OPERATIONALLY VERIFIED TO HAVE NO PROBLEMS OF ANY TYPE. HFV 8152 WAS FULLY SERVICED AND PASSED ALL APPLICABLE TESTING REQUIREMENTS. DATE OF INCIDENT WAS (B)(6) 2020. AT THAT TIME THE USER FACILITY ONLY NOTIFIED BUNNELL OF A POTENTIAL DISPLAY ISSUE. BASED ON THE INFORMATION INITIALLY PROVIDED THIS EVENT WAS DETERMINED TO NOT BE REPORTABLE. HOWEVER, AT THE TIME THE UNIT WAS RETURNED TO BUNNELL THE USER FACILITY NOTIFIED BUNNELL THAT THE PATIENT HAD PASSED AWAY; HOWEVER, THEY DID NOT SPECIFICALLY LINK THE PATIENT'S PASSING TO ANY POTENTIAL MALFUNCTION OF THIS DEVICE. BUNNELL'S AWARE DATE OF THE PATIENT'S CONDITION WAS (B)(4) 2020. THIS REPORT WAS COMPLETED WITHIN 30 DAYS OF THIS AWARENESS DATE.

    Description of Event or Problem · 1

    PATIENT WAS PLACED ON STANDBY ON THE JET FOR A PROCEDURE, WHEN PLACED BACK ON THE JET, THE MAP READ CONSISTENTLY 14.5 OR ABOVE, EVEN IF THE PEEP WAS TURNED DOWN TO 5 OR LESS. USER FACILITY PERFORMED THE FOLLOWING TROUBLESHOOTING: CHANGED OUT LIFEPORT ADAPTER. CHANGED OUT PATIENT BOX. PERFORMED A POWER ON SELF TEST - PASSED JUST FINE. PERFORMED AN OPERATIONAL TEST. THE PEEP WOULD READ ZERO BUT THE MAP NEVER READ LESS THAN 14.5 OR MORE. DISCONTINUED USE OF THE DEVICE AS TO NOT BE CHANGING SETTINGS INCORRECTLY. A BUNNELL HOTLINE CALL WAS RECEIVED AT THE TIME; HOWEVER, THE CALL DID NOT INVOLVE THE CONDITION OF A PATIENT, SETTINGS BEING UTILIZED ON THE PATIENT, OR FOR ADVICE ON MAKING ANY ADJUSTMENTS FOR THE PATIENT. RATHER, THE CALL INVOLVED POTENTIAL ISSUES WITH THE MONITORING SECTION OF THE LIFEPULSE VENTILATOR. IT WAS REPORTED THE JET HAD BEEN PLACED INTO STANDBY WHILE THE CARE TEAM TENDED TO A PROCEDURE WITH THE PATIENT. IT WAS REPORTED AT CONCLUSION OF THE PROCEDURE THE PATIENT WAS PLACED BACK ON THE LIFEPULSE AND ENTER WAS USED TO RESTART THE DEVICE. IT WAS REPORTED IT WAS AT THIS TIME THEY NOTICED THE MONITORED NUMBERS AND CALLED THE HOTLINE. AT NO TIME WAS INFORMATION ABOUT THE PATIENT PATHOPHYSIOLOGY, SITUATION, CONDITION, OR CARE PLAN PROVIDED TO BUNNELL. BUNNELL WAS NOT MADE AWARE OF THE PATIENT'S CONDITION UNTIL THE UNIT WAS BEING RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529339 BUNNELL LIFEPULSE LIFEPULSE HIGH FREQUENCY VENTILATOR LSZ BUNNELL, INC. 203

    Patients

    Seq Age Sex Outcome Treatment
    1