BEUDAMED
    FDA Adverse Event Other Summary report: N

    OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM

    MDR report key: 423086 · Received October 21, 2002

    Report

    Report Number
    2025525-2002-00031
    Event Type
    Other
    Date Received
    October 21, 2002
    Date of Event
    October 9, 2001
    Report Date
    October 8, 2002
    Manufacturer
    NELLCOR PURITAN BENNETT, INC.
    Product Code
    MMA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMPANY RECEIVED A REPORT OF A PATIENT WHO EXPERIENCED NEONATAL DEPRESSION AND ACIDOSIS AFTER REASSURING SATURATIONS. FSPO2 READINGS WERE REPORTED TO BE WITHIN 40-44%, NAD NO FHR ABNORMALITIES WERE OBSERVED WITH SENSOR PLACEMENT. IT WAS NOTED THAT DURING A PERIOD OF NON-REASSURING FHR TRACING, THE FSPO2 STOPPED TRACING. FOLLOWING A PERIOD OF BRADYCARDIA, CLINICIANS ELECTED TO PERFORM CESAREAN SECTION. NO INFORMATION WAS AVAILABLE FOR FHR FOR MORE THAN 25 MINUTES PRIOR TO DELIVERY. INITIAL APGAR SCORE WAS REPORTED TO BE ZERO. THE PATIENT WAS SUCCESSFULLY RESUSCITATED FOLLOWING BIRTH, AND HAS BEEN DISCHARGED.

    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 UNKNOWN Hospitalization| R