BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFE PULS HIGH FREQ. VENTILATOR & PATIENT BOX

    MDR report key: 1006524 · Received February 28, 2008

    Report

    Report Number
    1719232-2008-00002
    Event Type
    Other
    Date Received
    February 28, 2008
    Date of Event
    December 30, 2007
    Report Date
    February 28, 2007
    Manufacturer
    BUNNELL, INC.
    Product Code
    LSZ
    PMA / PMN Number
    P850064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS VENTILATOR WAS ORIGINALLY SET-UP TO COME BACK FOR A ROUTINE PM. ON 02/11/08, BUNNELL RECEIVED A COPY OF THE HOSPITAL'S MEDWATCH NOTIFICATION FROM THE FDA REGARDING THIS EQUIPMENT. AT THE TIME THIS WORKSHEET WAS CREATED, IT WAS UNK TO THE INDIVIDUAL SCHEDULING THE SVC THAT THERE WAS A PROBLEM WITH THE VENTILATOR THAT NEEDED TO BE REPORTED TO BUNNELL. WE CONTACTED THE HOSP TO OBTAIN FURTHER INFO REGARDING THE MEDWATCH NOTIFICATION, AND SPOKE WITH THE DIRECTOR OF THE RESPIRATORY CARE DEPT ON FIVE DAYS LATER. (DIR) CONFIRMED THAT THE INFO DESCRIBED ON THE MEDWATCH NOTIFICATION WAS ACCURATE TO HER UNDERSTANDING (QUOTED AS A NOTE BELOW), AND THAT OPERATOR ERROR WAS MORE THAN LIKELY RESPONSIBLE FOR THIS EVENT. FROM MEDWATCH NOTIFICATION: "EVENT DESC: PT WAS BEING CONNECTED TO A JET HIGH FREQUENCY VENTILATOR. DURING THE PROCESS, THE VENTILATOR MUST BE MANUALLY PUT ON STAND BY. THE RESPIRATORY THERAPIST DID NOT DO SO AND AS SOON AS THE PT WAS CONNECTED VENTILATOR, IT IMMEDIATELY PRESSURIZED AND PT SUSTAINED BILATERAL PNEUMOTHORACES." "WHAT WAS THE ORIGINAL INTENDED PROCEDURE? PLACE PT ON VENT, DUE TO RESPIRATORY DISTRESS." THE HFV/PB SYS WAS INVESTIGATED FOR OPERATIONAL MALFUNCTIONS AND NONE WERE FOUND. THE HFV/PB SYS WAS OPERATED FOR 12 DAYS WITH NO MALFUNCTIONS IN VENTILATION AND NO ALARM CONDITIONS OCCURRED. OPERATIONAL VERIFICATION SECTIONS OF CD-253 WERE PERFORMED AND NO MALFUNCTION WERE IDENTIFIED. AS DESCRIBED ABOVE, IN THAT " AS SOON AS IT IMMEDIATELY PRESSURIZED.", THE VENTILATOR DOES NOT PRESSURIZE 'IMMEDIATELY' WHEN INITIALLY CONNECTED. PRESSURE BUILDS GRADUALLY, 30 SECONDS, DUE TO THE RESTRICTED FLOW OF THE PULSE WIDTH MODULATION VALVES OF THE PNEUMATICS ASSEMBLY. IF VENTILATION IS INITIATED WITHOUT CONNECTION TO THE LIFEPORT ADAPTER FOR GAS DELIVERY, THEN THE HFV 'IMMEDIATELY' GOES TO A LOSS OF PIP ALARM AND SHUTS DOWN THE PWM VALVES, HALTING GAS FLOW. NO KNOWN CONDITIONS FOR EXCESS GAS PRESSURE EXIST WHEN THE OPERATOR STARTS FROM STANDBY OR DIRECTLY FROM POWER ON. EVEN WITH THE UNIT BEING POWERED ON, THE DUMP VALVE OF THE PNEUMATICS ASSEMBLY IS OPEN AND THE HFV MUST FIRST GO TO STANDBY MODE WITH THE DUMP VALVE OPEN. THUS NO PRESSURE CAN BE 'PRE-BUILT' INTO THE SYS. NO PROBLEMS WERE IDENTIFIED WITH THE DUMP VALVE OPERATION IN THE TESTING PROCESS. THE REPORTED SYMPTOM OF PRESSURIZED GAS BEING RELEASED TO THE PT COULD NOT BE REPRODUCED. THE HFV/PB SYS WAS OPERATED FOR 12 DAYS WITH NO MALFUNCTIONS OR ALARM CONDITIONS. OPERATIONAL VERIFICATION SECTIONS OF CD-253 WERE PERFORMED VERIFYING FULL FUNCTIONALITY OF THE HFV/PB SYS AND THAT THE HFV/PB SYS OPERATES AS SPECIFIED. FROM AN INITIAL START UP, THE HFV/PB SYS CANNOT "IMMEDIATELY" DELIVER PRESSURIZED GAS. BECAUSE THE RESTRICTED FLOW OF THE PULSE WIDTH MODULATION VALVES, THE SYS PRESSURE BUILDS WITH TIME. AT THIS TIME MALFUNCTION IS CONSIDERED OPERATOR ERROR OR POTENTIALLY A PROBLEM WITH THE CONVENTIONAL VENTILATOR USED IN CONJUNCTION WITH THE HFV/PB SYS.

    Description of Event or Problem · 1

    WE RECEIVED A COPY OF THE HOSPITAL'S MEDWATCH FORM FROM THE FDA ON 2/11/08. WE HAD RECEIVED NO REPORT OF THIS EVENT FROM THE HOSP. BY COINCIDENCE, THE VENTILATOR & PT BOX WERE HERE IN-HOUSE FOR PREVENTIVE MAINTENANCE AT THE TIME THE MEDWATCH COPY WAS RECEIVED. WHEN WE CONTACTED THE EQUIPMENT MGR IN THEIR RESPIRATORY CARE DEPT. WHO SENT THE DEVICE BACK TO US FOR SVC, HE WAS COMPLETELY UNAWARE OF THIS EVENT. THE HOSPITAL'S MEDWATCH FORM STATED THE BABY WAS BEING CONNECTED TO THE HIGH FREQUENCY VENTILATOR. DURING THE PROCESS, THE VENTILATOR MUST BE PUT IN STANDBY MODE. THE RESPIRATORY THERAPIST DID NOT DO SO, AND AS SOON AS THE PT WAS CONNECTED TO THE VENTILATOR, IT IMMEDIATELY PRESSURIZED & THE BABY SUSTAINED BILATERAL PNEUMOTHORACIES. THE VENTILATOR DOES NOT PRESSURIZE IMMEDIATELY WHEN INITIALLY CONNECTED. PRESSURE BUILDS GRADUALLY DUE TO THE RESTRICTED FLOW OF THE PULSE WIDTH MODULATION VALVES OF THE PNEUMATICS ASSEMBLY. THE VENTILATOR AND PT BOX SYS WAS OPERATED BY US FOR 12 DAYS WITH NO MALFUNCTIONS OR ALARM CONDITIONS. AT THIS TIME, THIS IS CONSIDERED TO BE OPERATOR ERROR OR POTENTIALLY A PROBLEM WITH THE CONVENTIONAL VENTILATOR USED IN CONJUNCTION WITH THE VENTILATOR/PT BOX SYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFE PULS HIGH FREQ. VENTILATOR & PATIENT BOX HIGH FREQUENCY VENTILATOR LSZ BUNNELL, INC. 203 / 312 7A0004 / 5F0259

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Required Intervention