BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONIN

    MDR report key: 312351 · Received January 12, 2001

    Report

    Report Number
    312351
    Event Type
    Injury
    Date Received
    January 12, 2001
    Date of Event
    May 31, 2000
    Report Date
    June 28, 2000
    Manufacturer
    NONIN MEDICAL INC.
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS PT HAS 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 OX 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 OX EQUIPMENT WAS EXAMINED BY HOSP'S CLINICAL ENGINEERING STAFF AND RESPIRATORY THERAPY STAFF. NO PROBLEMS WITH THE EQUIPMENT COULD BE IDENTIFIED. QUESTION IF ALARM OR PULSE OX WAS TURNED DOWN OR OFF. PULSE OX IS BEING SENT TO THE MFR FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1555 NONIN PULSE OX DQA NONIN MEDICAL INC. 8800 *

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention