BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BUNNELL INC. LIFE PULSE HIGH FREQUENCY VENTILATOR

    MDR report key: 2177440 · Received July 20, 2011

    Report

    Report Number
    MW5021474
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 2011
    Manufacturer
    BUNNELL INC.
    Product Code
    LSZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) GESTATION BABY IN NICU. AT APPROXIMATELY 2 AM, RN AND MD NOTED THAT BABY'S CHEST RISING AND FALLING VERY RAPIDLY. MD DESCRIBED IT AS "BABY LOOKED LIKE HE WAS GOING TO BOUNCE OUT OF THE BASSINET." RT TO BEDSIDE IMMEDIATELY, VENT SETTINGS ON BUNNELL LIFE PULSE HIGH FREQUENCY VENT ADJUSTED WITH NO CHANGE IN BABY'S CHEST RISING AND FALLING. BABY REMOVED FROM THE JET VENT AND PLACED ON REGULAR VENT FOR APPROX. FIFTEEN MINUTES WHILE A NEW JET VENT WAS OBTAINED. BLOOD GASES DRAWN AFTER THIS. PH AT 11:30PM ON (B)(6) WAS 7.317, AFTER EVENT AT 2:53 AM 7.829. BABY'S PCO2 AT 11:30 PM ON (B)(6) WAS 49.4, AFTER EVENT AT 2:53M ON (B)(6) IT WAS 6.6. UNSURE OF OUTCOME FOR BABY AT THIS TIME, MD ALERTING PARENTS TO ISSUE. DATES OF USE: (B)(6) 2011.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DA Hospitalization| L| S