BEUDAMED
    FDA Adverse Event Summary report: N

    CO2 MONITOR

    MDR report key: 33091 · Received May 13, 1996

    Report

    Report Number
    33091
    Date Received
    May 13, 1996
    Date of Event
    April 23, 1956
    Report Date
    May 13, 1996
    Manufacturer
    NELLCOR PURITAN BENNETT, INC.
    Product Code
    CCK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING OP SURGICAL PROCEDURE, MULTIPARAMETER MONITORING MACHINE FROZE UP. WAS INCAPABLE OF MONITORING THE PT DURING SURGERY. BIOMED CALLED STAT FOR MONITOR REPLACEMENT. NO INJURY TO PT. MONITOR REMOVED FROM INVENTORY AND MFR CONTACTED. BIOMEDICAL ENGINEERING STATEMENT SUGGESTS ASSOCIATION WITH MONITOR FAILURE TO THE FIRING OF ELECTRO SURGICAL UNIT (ESU) WHICH WAS USED IN SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CO2 MONITOR CO2 MONITOR CCK NELLCOR PURITAN BENNETT, INC. N-2500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO