BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUNNELL LIFEPULSE

    MDR report key: 17607995 · Received August 23, 2023

    Report

    Report Number
    1719232-2023-00003
    Event Type
    Malfunction
    Date Received
    August 23, 2023
    Date of Event
    June 4, 2023
    Report Date
    August 21, 2023
    Manufacturer
    BUNNELL, INC.
    Product Code
    LSZ
    PMA / PMN Number
    P850064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    USER FACILITY NOTIFIED BUNNELL OF EVENT ON 06/05/2023. INVESTIGATION COMPLETED 06/22/2023. GIVEN INVESTIGATION RESULTS, IT WAS DETERMINED THIS EVENT WAS NOT REPORTABLE. USER FACILITY REPORT (B)(4) RECEIVED 06/22/2023. REVIEW OF THIS REPORT DID NOT AFFECT REPORTABILITY DETERMINATION. THIS EVENT IS NOT REPORTABLE. FDA REQUEST FOR ADDITIONAL INFORMATION RECEIVED 07/25/2023. THIS REPORT SUBMITTED IN RESPONSE TO THIS REQUEST. INVESTIGATION OF THIS EVENT CONCLUDED THAT "THE REPORTED SYMPTOM (BATTERY ISSUE, JET SHUT DOWN) COULD NOT BE VERIFIED AND WAS NOT REPRODUCED AS REPORTED. OPERATION WAS VERY STABLE IN THE HFV READY CONDITION WITH NO ALARMS OF ANY TYPE GENERATED AND THE BATTERY WAS VERIFIED TO BE FULLY CHARGED. THE CHARGING CIRCUITY OF THE VENT WAS VERIFIED TO BE OPERATING CORRECTLY. THE INITIAL BATTERY RUNTIME WAS FOUND TO BE WELL WITHIN PUBLISHED MINIMUM RUNTIME SPECIFICATIONS (RUNTIME VERIFIED TO BE OVER 45 MINUTES). THE SYSTEMS CALIBRATION WAS OPTIMIZED FOR PEAK PERFORMANCE AND ALL CONTROL AND MONITORING CIRCUITRY WAS VERIFIED TO BE RESPONDING CORRECTLY TO ALL INPUT VARIATIONS. THE HFV WAS 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. HFV FI SUBJECT UNIT WAS FULLY SERVICED AND PASSED ALL APPLICABLE TESTING REQUIREMENTS."

    Description of Event or Problem · 0

    AS REPORTED TO BUNNELL ON 06/05/2023: "BATTERY ISSUE, JET SHUT DOWN." AS REPORTED ON USER FACILITY REPORT (B)(4): "CALLED TO PATIENT ROOM FOR MALFUNCTIONING JET VENT ALARMS WENT OFF AND VENT LOST PRESSURE. ATTEMPTED TO RESTART BUT IT WOULD NOT PRESSURIZE & ALL OF THE ALARMS ON FACE OF JET LIT UP & THEN THE VENT SHUT DOWN. REPLACE WITH ANOTHER JET."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1263956 BUNNELL LIFEPULSE LIFEPULSE HFV LSZ BUNNELL, INC. 204

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown