BEUDAMED
    FDA Adverse Event Death Summary report: N

    NONIN

    MDR report key: 288493 · Received July 24, 2000

    Report

    Report Number
    2183646-2000-00001
    Event Type
    Death
    Date Received
    July 24, 2000
    Date of Event
    May 31, 2000
    Report Date
    June 28, 2000
    Manufacturer
    NONIN MEDICAL, INC.
    Product Code
    DQA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS PT HAD SIGNIFICANT IMPAIRMENT FROM NEURO-MUSCULAR DISEASE. THE PT WAS BEING WEANED OFF THE VENTILATOR AND HAD BEEN DOING VERY WELL FOR 3 TO 4 DAYS WITH NO SPECIFIC PROBLEMS NOTED. THE PT WAS ATTACHED TO A PULSE OXYGEN MONITOR DURING THE WEANING PROCESS. THE PT WAS FOUND UNRESPONSIVE BY STAFF, HOWEVER, NO ALARM WAS HEARD. A CODE WAS CALLED AND THE PT WAS REVIVED. THE PT WAS PLACED BACK ON THE VENTILATOR WITH DECREASED FUNCTION. THE FAMILY OF THE PT CHOSE TO DISCONTINUE LIFE SUPPORT. THE PULSE OXYGEN EQUIPMENT WAS EXAMINED BY CLINICAL ENGINEERING STAFF AND RESPIRATORY THERAPY STAFF. NO PROBLEMS WITH THE EQUIPMENT COULD BE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONIN PULSE OX DQA NONIN MEDICAL, INC. 8800 *

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention