BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXIFIRST

    MDR report key: 392119 · Received April 25, 2002

    Report

    Report Number
    MW1024893
    Event Type
    Injury
    Date Received
    April 25, 2002
    Date of Event
    April 25, 2002
    Report Date
    April 25, 2002
    Manufacturer
    MALLINCKRODT INC. HEALTHY MOTHER AND BABY DIV
    Product Code
    MMA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DR WAS USING THE NELLCOR N-400 FETAL OXYGEN SATURATION MONITORING SYSTEM ON A PT WHO WAS HAVING REPETITIVE SEVERE VARIABLE DECELERATIONS. THE RESIDENT ON LABOR PLACED THE NELLCOR N-400 MONITORING DEVICE FOR ADD'L INFO. THE PT CONTINUED TO HAVE REPETITIVE SEVERE VARIABLE DECELERATIONS, HOWEVER THEY WERE REASSURED BY THE FETAL OXIMETRY RESULTS (> 50). WHEN THE PT BECAME COMPLETELY DILATED, THEY STARTED PUSHING. THE VARIABLES BECAME WORSE BUT THE FETAL OXYGEN SATURATION MONITOR CONTINUED TO GIVE REASSURING RESULTS (>50). DR DELIVERED THE PT WITH A VACUUM EXTRACTOR WITHOUT DIFFICULTY. THE PT HAD VERY LOW APGAR SCORES; 1, 5, 5 AT 1 MIN, 5 MINS AND 10 MINS, RESPECTIVELY. THE PT REQUIRED ASSISTED VENTILATION WITH BAG AND MASK AND WAS EVENTUALLY INTUBATED FOR MECHANICAL VENTILATION. THE PT WAS DELIVERED APPROX 10 MINS FOLLOWING A FETAL OXYGEN SATURATION READING OF 58. DR WANTS TO MAKE THE FDA AWARE OF THIS OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXIFIRST N-400 FETAL OXYGEN SATURATION SYSTEM MMA MALLINCKRODT INC. HEALTHY MOTHER AND BABY DIV * *

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Life Threatening 1) FETAL SCALP ELECTRODE FOR CONTINUOUS FETAL| CATHETER.| HEART RATE MONITORING. INTRAUTERINE PRESSURE