BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATHENA

    MDR report key: 320895 · Received March 14, 2001

    Report

    Report Number
    320895
    Event Type
    Injury
    Date Received
    March 14, 2001
    Date of Event
    February 13, 2001
    Report Date
    March 12, 2001
    Manufacturer
    S & W MEDICO TEKNIK
    Product Code
    DRT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ONGOING PROBLEMS WITH ATHENA ECG/RESPIRATORY MODULE NEONATAL 9050 MONITOR. PT FOUND DUSKY AND BLUE AND EXTUBATED WITH OXYGEN SATURATION IN 50'S. ATHENA MONITOR SCREEN WAS BLANK (NO READOUTS) OTHER THAN AT TOP OF SCREEN IT READ "HEALTH PARTNERS" AND BOTTOM LEFT CORNER OF SCREEN, A BLUE BOX WITH MONITOR SET-UP WRIITTEN INSIDE. EMERGENCY INTUBATION DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11350 ATHENA NEONATAL BEDSIDE MONITOR DRT S & W MEDICO TEKNIK 9050 *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Required Intervention