BEUDAMED
    FDA Adverse Event Other Summary report: N

    OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM

    MDR report key: 413274 · Received August 23, 2002

    Report

    Report Number
    2025525-2002-00022
    Event Type
    Other
    Date Received
    August 23, 2002
    Date of Event
    May 31, 2002
    Report Date
    August 22, 2002
    Manufacturer
    NELLCOR PURITAN BENNETT, INC.
    Product Code
    MMA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NELLCOR PURITAN BENNETT RECEIVED INFO STATING THAT AN N-400 FETAL OXYGEN SATURATION MONITOR SYSTEM WAS PLACED AT 2045. INITIAL VALUES WERE 40-50%, FALLING TO 30% AT 2050 FSP02 TRACING WAS LOST THREE TIMES DURING MONITORING PERIOD. FSP02 VALUES WERE IN THE 25-50% RANGE THROUGH OUT. PT WAS DISCHARGED HOME WITH NO PROBLEMS. NO PRODUCT WILL BE RETURNED, MONITOR SERIAL NUMBER NOR SENSOR LOT NUMBER ARE KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM FETAL PULSE OXIMETER MMA NELLCOR PURITAN BENNETT, INC. N400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY