BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEOBAR

    MDR report key: 1611606 · Received February 22, 2010

    Report

    Report Number
    2025917-2010-00001
    Event Type
    Death
    Date Received
    February 22, 2010
    Date of Event
    January 8, 2010
    Report Date
    February 2, 2010
    Manufacturer
    NEOTECH PRODUCTS, INC.
    Product Code
    CBH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TEST OF ACTUAL UNIT RETURNED FROM (B) (6) HOSPITAL: THE HOSPITAL RETURNED THE FAILED UNIT (NEOBAR N715F) TO US WITHIN A WEEK OF THE INCIDENT. THE TAB ON ONE SIDE WAS MISSING, BUT THE OTHER WAS INTACT. USING THE CHATILLON GAUGE, WE DID A PULL TEST AND FOUND THAT THE INTACT TAB DID NOT COME OFF THE BAR UNTIL A PULL FORCE OF 23LBS WAS APPLIED. THIS WOULD BE CONSIDERABLY MORE THAN ANY KNOWN FORCE THE BAR WOULD BE SUBJECTED TO DURING USE IN THE NICU, WHILE ATTACHED TO NEONATES.

    Description of Event or Problem · 1

    A BABY DETERMINED TO BE TERMINAL WAS TO HAVE THE LIFE SUPPORT SYSTEMS DISCONTINUED AFTER THE MORNING VISIT OF THE PARENTS. AT 2 AM ON THE MORNING OF (B) (6) 2010, THERE WAS AN ACCIDENTAL EXTUBATION OF THE ENDOTRACHEAL TUBE. THIS WAS SECONDARY TO THE PLASTIC LIMB OF THE SECURING DEVICE (NEOTECH NEOBAR) FOR THE ENDOTRACHEAL TUBE SLIPPING OUT OF THE TAB ON ONE SIDE. THIS TAB HOLDS THE PLASTIC BAR TO THE PATIENT'S FACE AND THUS IMMOBILIZES THE ENDOTRACHEAL TUBE. AN ATTEMPT WAS MADE TO RE-INTUBATE THE TUBE, BUT WAS UNSUCCESSFUL DUE TO THE EDEMATOUS UPPER AIRWAY. THE PROFESSIONAL STAFF ELECTED NOT TO PERFORM ANY OTHER HEROIC MEASURES TO OBTAIN AN AIRWAY AT THIS TIME. THUS, THEY TERMINATED THE LIFE SUPPORT AT THIS TIME AND DID NOT WAIT TO DO THE SAME LATER IN THE DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOBAR ENDOTRACHEAL TUBE HOLDER CBH NEOTECH PRODUCTS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Death| L