BEUDAMED
    FDA Adverse Event Death Summary report: N

    MILLENNIUM INFANT VENTILATOR

    MDR report key: 2324633 · Received October 26, 2011

    Report

    Report Number
    2020676-2011-00007
    Event Type
    Death
    Date Received
    October 26, 2011
    Date of Event
    September 22, 2011
    Report Date
    October 26, 2011
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    CBK
    PMA / PMN Number
    K993167
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER WAS NOTIFIED OF THE INCIDENT ON (B)(6) 2011. THE DOCTOR STATED THAT THE SATURATION LEVELS WERE UNDER 50%. THE BABY HAD BEEN STABLE FOUR HOURS PRIOR TO INCIDENT WITH SATURATION LEVELS OF 100%. THEY TOOK THE BABY OFF OF THE VENTILATOR TO SUCTION THE TUBE. UPON RECONNECTING THE BABY TO THE VENT, THE NURSE HAD TROUBLE AS IT WAS HARD TO KEEP 100% SATURATION. THE SATURATION LEVEL KEPT DROPPING (B)(4) ALMOST GOT TO 0% SATURATION (BABY WAS TURNING BLUE), BUT THEY TOOK THE BABY OFF AND BAGGED HIM. WITHIN 2 BREATHS ON THE BAG, THE SATURATION LEVEL WAS BACK UP TO 100%. THEY TRIED CONNECTING THE BABY TO THE VENT AGAIN AND THE SAME THING HAPPENED WITH THE SATURATION LEVEL DROPPING TO 40-20, ONCE IT GOT TO 20, THEY TOOK THE BABY OFF AND BAGGED HIM AGAIN. THE DOCTOR'S FIRST IMPRESSION WAS THERE WAS NO OXYGEN COMING THROUGH OR THERE WAS A LEAK. A NEW CIRCUIT WAS TRIED, BUT THE LEVEL CONTINUED TO DROP. AS SOON AS THERE WAS NO OXYGEN COMING THROUGH OR THERE WAS A LEAK. A NEW CIRCUIT WAS TRIED, BUT THE LEVEL CONTINUED TO DROP. AS SOON AS THERE WAS NOT ENOUGH PRESSURE, THE BABY'S SATURATION LEVEL WOULD START DROPPING TOWARD "0". THE DOCTOR TRIED CHANGING THE OXYGEN SOURCE, FORM THE WALL TO ANOTHER SOURCE TO THE SAME SOURCE AS THE BAG. THE BABY'S SATURATION LEVEL WOULD DROP FROM THE TIME HE WAS RECONNECTED TO THE VENT. THE PRESSURE DID NOT GO DOWN AND REMAINED STABLE. THE VENT APPEARED TO BE WORKING BEAUTIFULLY (BASED ON THE SOUND). PER THE DOCTOR THEY BAGGED THE BABY 3 TIMES. THE DOCTOR STATED THE DEVICE DID NOT CONTRIBUTE OR CAUSE TO THE DEATH OF THE BABY. DOCTOR STATED THE BABY WAS VERY SICK AND WAS GOING TO EXPIRE. DOCTOR STATED THE RECOMMENDED PERFORMANCE VERIFICATION WAS NOT CONDUCTED. THE VENTILATOR WAS SWITCHED ON AND PARAMETERS SET. LAST PERFORMANCE VERIFICATION PERFORMED A MONTH AGO. VENTILATOR WAS TAKEN OUT OF SERVICE AND CHECK BY BIOMEDICAL TECHNICIAN. NO PROBLEM FOUND. THE DOCTOR STATED THE VENT HAD BEEN BROUGHT BACK TO THE NICU AFTER THE BIOMEDICAL DEPARTMENT DID NOT FIND ANYTHING WRONG WITH THE VENTILATOR. THE TECHNICIAN SHOWED HER ON A TEST LUNG THAT IS WAS WORKING PROPERLY. PER THE DOCTOR, THE BIOMEDICAL TECHNICIAN WAS UNABLE TO FIND ANYTHING WRONG WITH THE VENT. THE DOCTOR WAS ADVISED TO RETURN THE VENTILATOR TO THE MANUFACTURER TO PERFORM AND EVALUATION AND ENSURE THE DEVICE IS OPERATING PROPERLY. A REVIEW OF THE MANUFACTURER RECORDS DOSE NOT INDICATE THE DEVICE HAS UNDERGONE THE RECOMMENDED 2 YEAR OVERHAUL SINCE ITS MANUFACTURE DATE. THE DEVICE WAS RETURNED FOR EVALUATION. THE RESULTS SHOW THE NO VISIBLE INDICATION OF DAMAGE. THE VENTILATOR'S AIR/OXYGEN MIXER IS WITHIN THE OPERATING SPECIFICATIONS. THE VENTILATOR'S OPERATION SHOW IT IS OUT OF CALIBRATION IN REGARD TO MAXIMUM INSPIRATORY PRESSURE, MAXIMUM EXPIRATORY PRESSURE AND TRIGGER SENSITIVITY.

    Description of Event or Problem · 1

    BABY WAS CRITICALLY ILL AND WAS UNDERGOING TREATMENT FOR SEPSIS, PULMONARY HYPERTENSION, HYALINE MEMBRANE, MASSIVE INTRAVENTRICULAR HEMORRHAGE. DOCTOR WAS CALLED WHEN OXYGEN SATURATION LEVELS WERE NOTED BELOW 50%. NO ALARMS REPORTED. THE NURSE IN CHARGE BAGGED THE BABY AND WAS ABLE TO INCREASE THE SATURATION LEVEL TO 100%. DOCTOR REALIZED THE PROBLEM WAS WITH THE VENTILATOR AND COULD NOT CONNECT THE PT DUE TO CONTINUED DESATURATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILLENNIUM INFANT VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK SECHRIST INDUSTRIES, INC. MILLENNIUM

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA PASSPORT B DATASCOPE MONITOR