BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JET VENTILATOR

    MDR report key: 12057751 · Received June 24, 2021

    Report

    Report Number
    12057751
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Date of Event
    May 7, 2020
    Report Date
    June 15, 2021
    Manufacturer
    BUNNELL, INCORPORATED
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    NOTICED HEATER ON JET VENTILATOR OFF AND CIRCUIT COLD TO THE TOUCH, HEATER TURNED ON, HIGH LEVEL ALARM NOTED, TROUBLESHOOTING PERFORMED (CARTRIDGE RESEATED, CONNECTIONS CHECKED), WATER CYCLED INTO HUMIDIFIER, OVERFILLING CARTRIDGE, HIGH LEVEL ALARM WENT OFF, WATER ENTERED CIRCUIT AND LAVAGED PATIENT, PATIENT HR AND SPO2 DROPPED, ATTEMPTED TO SUCTION BUT SUCTION WAS NOT CONNECTED, MD AT BEDSIDE, PATIENT REMOVED FROM VENT, MD STARTED MANUAL RESUSCITATION, HR AND SPO2 QUICKLY INCREASED, ETT (ENDOTRACHEAL TUBE) SUCTIONED, WATER REMOVED FROM CIRCUIT PRIOR TO PLACING PATIENT BACK ON VENTILATOR. VENTILATOR WAS ALARMING HIGH-WATER LEVEL IN THE HUMIDIFIER OF THE JET BUNNELL. TROUBLESHOOTING GUIDE WAS REFERENCED WITHOUT RESULT. MANAGER AT BEDSIDE CALLED TECHNICAL SUPPORT AT BUNNELL. INSTRUCTION WAS GIVEN TO TURN THE HUMIDIFIER OFF FOR 15-20 MINUTES AND ALLOW THE WATER LEVEL TO EVAPORATE AS THE VENTILATOR WAS RUNNING AND THEN TURN THE HUMIDIFIER BACK ON AFTER THE APPROPRIATE TIME. TECHNICAL SUPPORT COMMUNICATED THAT THIS SHOULD RESOLVE THE ISSUE, AS OCCASIONALLY THE TUBING PULLS TOO MUCH WATER INTO THE CARTRIDGE UPON INITIATION OF THE VENTILATOR, TO NO FAULT OF THE OPERATOR. HE INSTRUCTED THAT THE ONLY OTHER OPTION WAS TO REMOVE THE PATIENT FROM THE VENTILATOR AND MANUALLY VENTILATE THEM WHILE EXTRACTING APPROXIMATELY 5 ML OF WATER FROM THE CARTRIDGE, IF THE PATIENT WAS STABLE ENOUGH TO TOLERATE BEING REMOVED FROM THE VENTILATOR. IT WAS DETERMINED THAT THE PATIENT WAS NOT STABLE ENOUGH TO TOLERATE AS VENTILATOR SETTINGS WERE HIGH, PATIENT WAS MAXED ON INO, WITH SATURATIONS IN THE 50'S. PARENTS WERE AT THE BEDSIDE AND VISIBLY DISTRESSED. THERAPIST WAS INSTRUCTED TO TURN THE VENTILATOR HUMIDIFIER BACK ON AFTER 20 MINUTES, IF THE HUMIDIFIER CONTINUED THE ISSUE TO REPEAT THE PROCESS UNTIL SUCH A TIME THAT THE PATIENT COULD BE REMOVED, AND SECONDARY PROCESS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956268 JET VENTILATOR VENTILATOR, HIGH FREQUENCY LSZ BUNNELL, INCORPORATED

    Patients

    Seq Age Sex Outcome Treatment
    1 365 DA