BEUDAMED
    FDA Adverse Event Death Summary report: N

    OXYGEN GAS REGULATOR-SINGLE STAGE

    MDR report key: 68767 · Received February 10, 1997

    Report

    Report Number
    2921585-1997-00001
    Event Type
    Death
    Date Received
    February 10, 1997
    Date of Event
    September 7, 1995
    Manufacturer
    SIERRA MANUFACTURING
    Product Code
    CAN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS MDR REPORT DOCUMENTS A REPORTABLE EVENT CONCERNING THE DEATH OF A SIX WEEK OLD INFANT WHO DIED FOLLOWING AN ALLEGED MALFUNCTION OF A GAS REGULATOR USED IN THE INFANT'S HOME. THE INFO REGARDING THE INCIDENT WAS ORIGINALLY RECEIVED BY CO ON 3/13/96 THROUGH ITS INSURANCE CARRIER AND SUBSEQUENTLY RELATED TO THE REGULATORY DEPT. ON 1/10/97. ACCORDING TO RECORDS PROVIDED, THE INFANT BECAME DISTRESSED DUE TO A LARGE AMOUNT OF FORMULA IN ITS MOUTH AND AIRWAY. THE MOTHER SUMMONED THE PARAMEDICS. WHEN THEY ARRIVED, THEY NOTICED THE FORMULA IN THE INFANT'S MOUTH WHICH THEY SUCTIONED. IT IS UNCLEAR WHETHER THE MOTHER INTENDED TO SUCTION THE INFANT'S MOUTH PRIOR TO APPLYING OXYGEN. THE MOTHER CLAIMS THE REGULATOR, WHICH IS MOUNTED AT THE TOP OF THE OXYGEN TANK, DISASSEMBLED PRIOR TO HER ATTEMPT TO ADMINISTER OXYGEN TO THE INFANT. SHE WAS UNABLE TO REASSEMBLE THE REGULATOR TO SUPPLY OXYGEN TO HER SON. THE PARAMEDICS RESUSCITATED THE CHILD, AND TRANSPORTED HIM TO THE HOSPITAL WHERE HE DIED TWO DAYS LATER AFTER A DECISION WAS MADE TO TERMINATE LIFE SUPPORTING SYSTEMS. THE HISTORY OF THE PT IS THAT OF A SIX WEEK OLD INFANT WITH BILATERAL CLEFT LIP AND PALATE, CLUB FEET, A VENTRAL-SEPTA DEFECT (VSD), ATRIAL SEPTAL DEFECT (ASD) OF OSTIUM SECUNDUM TYPE, AND AGENESIS OF THE CORPUS CALLOSUM. THE PEDIATRICIAN'S NOTES STATES THE CHILD HAD A TERMINAL CONDITION WITH POOR PROGNOSIS. THE PARENTS ULTIMATELY DECIDED TO TAKE THE INFANT HOME. AN OXYGEN TANK, REGULATOR AND CART, ALONG WITH SUCTION EQUIPMENT, WERE PROVIDED FOR THE PARENTS TO ADMINISTER TO THE INFANT AT HOME. THE OXYGEN SET UP WAS FOR PRN BLOW-BY ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXYGEN GAS REGULATOR-SINGLE STAGE (CLASS I) OXYGEN, FLOW GAUGE, 0.5 1PM 1 1/2" CAN SIERRA MANUFACTURING 707-870-FG5 *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Death O2 SETUP FOR PRN BLOW-BY USE ONLY,| D-TANK,| SUCTION EQUIPMENT| REGULATOR| CART