BEUDAMED
    FDA Adverse Event Summary report: N

    LIFE PULSE HIGH FREQUENCY VENTILATOR PATIENT BOX

    MDR report key: 592265 · Received April 8, 2005

    Report

    Report Number
    1719232-2005-00002
    Date Received
    April 8, 2005
    Manufacturer
    BUNNELL, INC.
    Product Code
    LSZ
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER TESTING S/N WITH ANOTHER S/N TO VERIFY IT WAS DELIVERING 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 18CM H2O, ROSE TO 45.6 CM H2O BEFORE DUMPING PRESSURE WITH A HIGH PIP ALARM. THE VENTILATOR/PATIENT BOX WERE TAKEN OFF THE PATIENT AND TESTED A SECOND TIME TO VERIFY IT WAS DELIVERING 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 PNUEMOTHARAX. BECAUSE BOTH SYSTEMS DELIVERED APPROPRIATE PRESSURES ON TEST PRIOR TO BEING ATTACHED TO THE PATIENT, IT APPEARS SOMETHING IN THE PATIENT 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 COMPANY OPERATORS MANUAL. GOING TO STAND BY DUMPS THE PRESSURE SO THAT, WHEN THE PATIENT IS STARTED ON VENTILATION, THEY START FROM ZERO PRESSURE. FACILITY CALLED LATER TO INFORM COMPANY THAT THE PATIENT HAD A SMALL PNUEMOTHRAXZ THAT WAS NEEDLE ASPIRATED AND RESOLVED COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFE PULSE HIGH FREQUENCY VENTILATOR PATIENT BOX INFANT VENTILATOR SYSTEM LSZ BUNNELL, INC. 312 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other