BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAINSTREAM CO2 SENSOR

    MDR report key: 18011474 · Received October 26, 2023

    Report

    Report Number
    18011474
    Event Type
    Malfunction
    Date Received
    October 26, 2023
    Date of Event
    September 7, 2023
    Report Date
    September 29, 2023
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TESTED END TIDAL PRIOR TO CONSCIOUS SEDATION HAD A WAVEFORM TOOK CANNULA OFF AS PT AGITATED WITH IT ON REPLACED AT START OF PROCEDURE WAS NOT ABLE TO OBTAIN WAVEFORM ATTEMPTED TO REPOSITION AND RESET UNSUCCESSFUL. AFTER SEDATION WAS TOLD IT HAD HAPPENED DURING PREVIOUS SEDATION IN SAME ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1567173 MAINSTREAM CO2 SENSOR MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 2190 DA Female