BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFE PULSE HIGH FREQUENCY VENTILATOR SYSTEM

    MDR report key: 794761 · Received December 11, 2006

    Report

    Report Number
    1719232-2006-00005
    Event Type
    Injury
    Date Received
    December 11, 2006
    Date of Event
    November 6, 2006
    Report Date
    December 6, 2006
    Manufacturer
    BUNNELL, INC.
    Product Code
    LSZ
    PMA / PMN Number
    P850064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY HAS BEEN ADVISED OF THE NEED TO CONDUCT A FAILURE INVESTIGATION AND HAS AGREED TO BRING THE DEVICE BACK FOR INVESTIGATION AFTER THE HOLIDAYS.

    Description of Event or Problem · 1

    A LARGE BREATH WAS DELIVERED TO THE PT. THE VENTILATOR WAS PLACED INTO THE STANDBY MODE & THEN THE ENTER BUTTON PRESSED TO RESTART IT, THE PT BOX VALVE DID NOT CYCLE AFTER PRESSING THE ENTER BUTTON. WHEN THE PT BOX WAS PICKED UP, THE VALVE STARTED CYCLING AND DELIVERED A LARGE BREATH TO THE PT. THE PT STATUS DETERIORATED AND A CHEST X-RAY REVEALED THE PT HAD BILATERAL PNEUMOTHORAX. BILATERAL THORACENTESIS WAS PERFORMED. FOLLOW UP X-RAY STILL SHOWED PNEUMOTHORAX ON THE LEFT SIDE. A CHEST TUBE WAS PLACED ON THE LEFT SIDE. FOLLOW UP X-RAY, THE NEXT DAY, SHOWED LEFT SIDE PNEUMOTHORAX RESOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 17 DAY Required Intervention