inforMED
MalfunctionCCK

OXY2MASK O2/ETCO2 ADULT

Received Apr 22, 2025 · Event occurred Apr 4, 2025

Report 21881996 · MDR key 21881996

Device

Generic name

Analyzer, Gas, Carbon-dioxide, Gaseous-phase

Manufacturer

Southmedic, Inc

Model number

OM-2125-14SLM

Catalog number

OM-2125-14SLM

Lot number

W1005506

Product problems

  • Incorrect Measurement
  • Incorrect, Inadequate or Imprecise Result or Readings

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

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.