BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLAR 8000

    MDR report key: 827534 · Received January 31, 2007

    Report

    Report Number
    827534
    Event Type
    Malfunction
    Date Received
    January 31, 2007
    Date of Event
    January 26, 2007
    Report Date
    January 31, 2007
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MARQUETTE MONITOR PULSE OXIMETER READING WAS BETWEEN 99-100, WITH HEART RATE BETWEEN 190-192; BUT BABY CRYING, IRRITABLE, AND DUSKY IN COLOR. NURSE PLACED BABY ON ANOTHER BRAND OF PULSE OXIMETER MONITOR, SATURATION READING WAS BETWEEN 71-73. NURSE FELT THIS TO BE MORE REFLECTIVE OF BABY'S CLINICAL PRESENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLAR 8000 PHYSIOLOGICAL MONITOR MHX GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO