BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXY2MASK O2/ETCO2 ADULT

    MDR report key: 21881996 · Received April 22, 2025

    Report

    Report Number
    21881996
    Event Type
    Malfunction
    Date Received
    April 22, 2025
    Date of Event
    April 4, 2025
    Report Date
    April 7, 2025
    Manufacturer
    SOUTHMEDIC, INC
    Product Code
    CCK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PER PROTOCOL, WE ARE SUPPOSED TO MONITOR ETCO2 [END-TIDAL CARBON DIOXIDE] ON ALL OF OUR PATIENTS WITH OSA [OBSTRUCTIVE SLEEP APNEA] WHO RECEIVE MODERATE SEDATION. WE CURRENTLY USE THE O2/ETCO2 ADULT OXYMASK TO BOTH PROVIDE OXYGEN AND MEASURE ETCO2. REFERENCE NUMBER OM-2125-14SLM. MULTIPLE NURSES HAVE HAD DIFFICULTY MEASURING ACCURATE CO2 [CARBON DIOXIDE] LEVELS ON OUR SEDATED PATIENTS, WHICH WE BELIEVE IS DUE TO THE EXCESSIVE LENGTH OF THE CO2 TUBING. WE ARE ALL GETTING READINGS BETWEEN 7-11 MMHG, WHEN THEY SHOULD BE 35-45 MMHG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1352214 OXY2MASK O2/ETCO2 ADULT ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE CCK SOUTHMEDIC, INC OM-2125-14SLM W1005506

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown