BEUDAMED
    FDA Adverse Event Death Summary report: N

    VYGON/GMP PRODUCTION

    MDR report key: 208022 · Received January 29, 1999

    Report

    Report Number
    208022
    Event Type
    Death
    Date Received
    January 29, 1999
    Date of Event
    January 14, 1999
    Report Date
    January 28, 1999
    Manufacturer
    VYGON
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 29-WEEK GESTATIONAL AGE FETUS DELIVERED VIA C-SECTION AT 15:05 ON 01/14/1999. HEART RATE > 100, APNEIC. IMMEDIATE RESUSCITATION WITH ORAL INTUBATION. ENDOTRACHEAL TUBE PLACEMENT CONFIRMED BY AUSCULTATION AND CHEST RISE; AND TAPED AT 7CM. HEART RATE FELL TO < 80, EPINEPHRINE GIVEN VIA ENDOTRACHEAL TUBE. TUBE NOTED TO BE AT 9CM; WAS READJUSTED AND SECURED AT 7CM. BABY SENT TO NEONATAL INTENSIVE CARE UNIT AND PLACED ON MECHANICAL VENTILATION. AFTER 15 SECONDS CHEST RISE NOT OBSERVED; AIR ENTRY ON RIGHT DIMINISHED. NEEDLE THORACENTESIS FOR CONTINUOUS RELEASE OF AIR. DESPITE DRAINAGE, BABY INCREASINGLY CYANOTIC, EXPIRING AT 16:28. PT EXPIRED AFTER 1 HR AND 23 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VYGON/GMP PRODUCTION ENDOTRACHEAL PEDIATRIC TUBE W/SECONDARY LUMEN BTR VYGON 15516.25 *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY Death| R