BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFE PULSE HIGH FREQUENCY VENTILATOR & PATIENT BO

    MDR report key: 1033288 · Received April 21, 2008

    Report

    Report Number
    1719232-2008-00003
    Event Type
    Injury
    Date Received
    April 21, 2008
    Date of Event
    October 21, 2007
    Report Date
    April 21, 2008
    Manufacturer
    BUNNELL, INC.
    Product Code
    LSZ
    PMA / PMN Number
    P850064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN OUR FAILURE INVESTIGATION, THE REPORTED SYMPTOM OF DELIVERING A LARGE BREATH/TIDAL VOLUME COULD NOT BE REPRODUCED. THE HIGH FREQUENCY VENTILATOR AND THE PT BOX WERE FOUND TO OPERATE AS SPECIFIED. THE INCIDENT IS CONSIDERED TO BE WITH THE CONVENTIONAL VENTILATOR OR USER ERROR. THE HIGH FREQUENCY VENTILATOR ALARMS ARE DESIGNED TO LIMIT THE POTENTIAL OF THE VENTILATOR BEING ABLE TO DELIVERY A LARGE TIDAL VOLUME. THE NORMAL POSITION OF THE PINCH VALVE IS IN THE CLOSED POSITION. THAT MEANS THE ONLY WAY THE VENTILATOR COULD DELIVERY A LARGE TIDAL VOLUME IS IF THE PINCH VALVE WAS HELD OPEN ELECTRICALLY OR MECHANICALLY. WITH EITHER SCENARIO, OR IF THE LARGE TIDAL VOLUME WAS DELIVERED VIA THE CONVENTIONAL VENTILATOR THE HIGH FREQUENCY VENTILATOR'S ALARM RESPONSE WOULD BE A HIGH PIP ALARM. SEE # 8 OF THE ATTACHED. FAILURE INVESTIGATION REPORT FORM.

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT A PT ON OUR HIGH FREQUENCY VENTILATOR SYSTEM HAD RECEIVED A LARGE TIDAL WAVE WHILE BEING VENTILATED AND OUR VENTILATOR MADE A WHOOSHING SOUND. THE PT'S OXYGEN SATURATION STARTED DROPPING, SO THE NURSE DISCONNECTED THE CONVENTIONAL VENTILATOR (CV) AND STARTED HAND BAGGING THE PT WHILE OUR HIGH FREQUENCY VENTILATOR WAS STILL RUNNING. OUR HIGH FREQUENCY VENTILATOR SHOWED NO ALARMS AND APPEARED TO BE RUNNING NORMALLY. THE PT WAS REMOVED FROM OUR HIGH FREQUENCY VENTILATOR SHORTLY AFTER THE INCIDENT. LATER, AN X-RAY SHOWED THE PT HAD BILATERAL PNEUMOTHORACES. THE PT WAS SUPPORTED ON HFOV UNTIL ANOTHER HIGH FREQUENCY VENTILATOR COULD BE SET UP AS A REPLACEMENT IN AN EFFORT TO RESOLVE THE PNEUMOTHORACES. LATER WE WERE TOLD THE PT HAD EXPIRED. THE HOSPITAL'S BIOMEDICAL DEPT. EVALUATED OUR HIGH FREQUENCY VENTILATOR WITH THE PT BOX. THE SYSTEM WAS RUN FOR 4 DAYS WITH NO MALFUNCTIONS OR ALARM CONDITIONS. EVEN THOUGH WE REPEATEDLY CONTACTED THE HOSP TO RETURN THE VENTILATOR AND PATIENT BOX FOR INVESTIGATION, THEY CONTINUED TO USE IT ON PTS OVER A LONG PERIOD. WE DID NOT RECEIVED THE UNITS BACK FOR INVESTIGATION UNTIL 3/17/2008. IN OUR FAILURE INVESTIGATION, THE REPORTED SYMPTOM OF DELIVERING A LARGE BREATH/TIDAL VOLUME COULD NOT BE REPRODUCED. THE HIGH FREQUENCY VENTILATOR AND THE PT BOX WERE FOUND TO OPERATED AS SPECIFIED. THE INCIDENT IS CONSIDERED TO BE WITH THE CONVENTIONAL VENTILATOR OR USER ERROR. THE HIGH FREQUENCY VENTILATOR ALARMS ARE DESIGNED TO LIMIT THE POTENTIAL OF THE VENTILATOR BEING ABLE TO DELIVER A LARGE TIDAL VOLUME. THE NORMAL POSITION OF THE PINCH VALVE IS IN THE CLOSED POSITION. THAT MEANS THE ONLY WAY THE VENTILATOR COULD DELIVER A LARGE TIDAL VOLUME IS IF THE PINCH VALVE WAS HELD OPEN ELECTRICALLY OR MECHANICALLY. WITH EITHER SCENARIO, OR IF THE LARGE TIDAL VOLUME WAS DELIVERED VIA THE CONVENTIONAL VENTILATOR THE HIGH FREQUENCY VENTILATOR'S ALARM RESPONSE WOULD BE A HIGH PIP ALARM. SEE # 8 OF THE ATTACHED. FAILURE INVESTIGATION REPORT FORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFE PULSE HIGH FREQUENCY VENTILATOR & PATIENT BO VENTILATOR LSZ BUNNELL, INC. 203/310

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention USED WITH A CONVENTIONAL VENTILATOR