BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFE PULSE HIGH FREQUENCY VENTILATOR

    MDR report key: 573557 · Received April 8, 2005

    Report

    Report Number
    1719232-2005-00001
    Event Type
    Other
    Date Received
    April 8, 2005
    Date of Event
    January 13, 2005
    Report Date
    February 2, 2005
    Manufacturer
    BUNNELL, INC.
    Product Code
    LSZ
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    AFTER TESTING TO VERIFY IT WAS DELIVERYING THE PROPER PRESSURE, THEY ATTACHED THE VENTILATOR AND PATIENT BOX TO THE PATIENT WITHOUT PUTTING THE SYSTEM IN STANDBY MODE. THE PIP WAS SET AT 18 CM H20 ROSE TO 45.6 CM H20 BEFORE DUMPING PRESSURE WITH A HIGH PIP ALARM. THE VENTILATOR PATIENT BOX WERE TAKEN OFF THE PATIENT AND T ESTED A SECOND TIME TO VERIFY IT WAS DELIVERYING 18 CM H20. IT WAS AGAIN ATTACHED TO THE PATIENT WITHOUT GOING TO STANDBY WITH THE SAME RESULT. THE VENTILATOR & PATIENT BOX WERE SWITCHED TO ANOTHER VENTILATOR & PATIENT BOX BUT THE PRESSURE ONLY WENT TO 20.7 CM H20. AT THIS POINT, IT WAS IDENTIFIED THAT THE PATIENT HAD A PNEUMOTHORAX. BECAUSE BOTH SYSTEMS DELIVERED APPROPRIATE PRESSURES ON TEST PRIOR TO BEING ATTACHED TO THE PATIENT, IT APPEARS SOMETHING IN THEPATIENT OR THE PATIENT'S AIRWAY MAY HAVE CHANGED BETWEEN STARTING THE FIRST SYSTEM AND REPLACING IT WITH THE SECOND SYSTEM. IT IS NOT APPROPRIATE TO START A PATIENT ON THE VENTILATOR WITHOUT GOING TO STANDBY FIRST AS INSTRUCTED IN OUR OPERATOR'S MANUAL. GOING TO STANDBY DUMPS THE PRESSURE SO THAT, WHEN THE PATIENT IS STARTED ON VENTILATION, THEY START FROM ZERO PRESSURE. CALLED LATER TO INFORM ;US THAT THE PATIENT HAD A SMALL PNEUMOTHORAX THAT WAS NEEDLE ASPIRATED AND RESOLVED COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFE PULSE HIGH FREQUENCY VENTILATOR INFANT VENTILATOR LSZ BUNNELL, INC. 203 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other