BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BUNNELL PATIENT CIRCUIT

    MDR report key: 10123112 · Received June 5, 2020

    Report

    Report Number
    1719232-2020-00001
    Event Type
    Injury
    Date Received
    June 5, 2020
    Date of Event
    May 5, 2020
    Report Date
    May 29, 2020
    Manufacturer
    BUNNELL, INC.
    Product Code
    LSZ
    PMA / PMN Number
    P850064
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED SYMPTOM THAT PBC 20010396 DELIVERED LARGE AMOUNTS OF WATER TO THE PATIENT COULD NOT BE VERIFIED AND WAS NOT REPRODUCED AS REPORTED. LONG TERM OPERATIONAL TESTING FOR OVER 7 DAYS NEVER RESULTED IN EXCESSIVE HUMIDIFICATION OR RAIN OUT BEING GENERATED WITHIN THE CIRCUIT GAS OUT TUBING AND NO ALARMS OF ANY TYPE WERE GENERATED. THE MONITORED TEMPERATURES REMAINED VERY STABLE AND ACCURATE. THE MONITORED PIP, PEEP, SERVO PRESSURE AND MAP ALL REMAINED VERY STABLE WITH MINIMUM FLUCTUATIONS THROUGHOUT THE TESTING PERIOD. THE LEVEL SENSE PINS WERE VERIFIED TO BE OPERATING AND RESPONDING CORRECTLY AND THE CARTRIDGE CONSISTENTLY FILLED TO THE CORRECT LEVEL. THE INITIAL ELECTRICAL RESPONSE CHARACTERISTICS WERE VERIFIED TO BE WELL WITHIN SYSTEMS SPECIFICATIONS AND THERE WERE NO OPERATIONAL OR CHARACTERISTIC DEGRADATION OF THE PATIENT BREATHING CIRCUIT RELATIVE TO THE INITIAL ANALYSIS FOLLOWING LONG TERM OPERATIONAL VERIFICATION TESTING. THERE IS NOTHING WRONG WITH THIS PATIENT BREATHING CIRCUIT FROM LOT NUMBER 20010396. IT SHOULD BE NOTED THAT, PER THE USER FACILITY'S REPORT TO BUNNELL, THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS EVENT. HOWEVER, AS THERE IS A POTENTIAL FOR INJURY IF THE EVENT REOCCURRED, AND OUT OF AN ABUNDANCE OF CAUTION, THIS EVENT IS BEING SUBMITTED AS A 30-DAY REPORT.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT THEY EXPERIENCED "A JET CIRCUIT MALFUNCTION THAT WAS NEW ON A PATIENT AND WAS NOTED TO BE DELIVERING LARGE AMOUNTS OF WATER TO THE 22 WEAKER IT WAS ON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586523 BUNNELL PATIENT CIRCUIT HFV PATIENT BREATHING CIRCUIT LSZ BUNNELL, INC. 00212 20010396

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention