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NA OLG-2800ARecalls & reported problems

Nihon Kohden Corporation · Carbon Dioxide Monitor · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04931921103814), received between Jul 9, 2018 and Aug 20, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Inaudible or Unclear Audible Prompt/Feedback” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Inaudible or Unclear Audible Prompt/Feedback1
  • Incorrect Interpretation of Signal1

Patient problems

  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 20, 2019Inaudible or Unclear Audible Prompt/Feedback; Inaudible or Unclear Audible Prompt/Feedback

    THE CUSTOMER REPORTED THAT THIS STAND-ALONE ETCO2 MONITOR (OLG-2800) ALARM SOUND IS VERY QUIET AND THAT THEY CANNOT HEAR IT AT THE NURSE'S STATION. NO CONSEQUENCE OR IMPACT TO THE PATIENT WAS REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8913542 ↗
  • MalfunctionJul 9, 2018Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

    THE NURSE REPORTED THAT THE CO2 MONITOR WAS DELIVERING INACCURATE READINGS, AND THAT IT WAS BEING CAUSED BY THE HIGH FLOW RATE OF THE NASAL CANNULA.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7671848 ↗

Other ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.