Skip to content

tc Sensor 84 945-737Recalls & reported problems

Radiometer Medical ApS · tc Sensor 84, pCO2/pO2 · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05700699457370), received between May 6, 2020 and May 6, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Off-Label Use” (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

  • Off-Label Use1
  • Patient Device Interaction Problem1

Patient problems

  • Burn(s)1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 6, 2020Off-Label Use; Patient Device Interaction Problem; Off-Label Use; Patient Device Interaction Problem

    ACCORDING TO THE COMPLAINT, THE SKIN OF THE PATIENT STARTED TO SHOW REDNESS/SLIGHT BURN UNDER THE SENSOR DURING THE DEVICE MEASUREMENT ULTIMATELY LEAVING A BLISTER. STAFF REDUCED TEMP FROM 44'C TO 40'C DURING THE EXAMINATION IN THE EVENT THAT THE HEAT OF THE SENSOR WAS THE ISSUE.

    Patient problems: Burn(s)

    MAUDE report 10028382 ↗

Other MONITOR, CARBON-DIOXIDE, CUTANEOUS devices

All MONITOR, CARBON-DIOXIDE, CUTANEOUS devices →

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