SpotOn™ 37000Recalls & reported problems
3m Company · 3M™ SpotOn™ Temperature Monitoring System 37000 · 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 00608223370001), received between Nov 1, 2023 and Nov 1, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Electromagnetic Compatibility Problem” (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.
Reports received per month
Most reported problems
Device problems
- Electromagnetic Compatibility Problem1
Patient problems
- Oversedation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 1, 2023Electromagnetic Compatibility Problem; Electromagnetic Compatibility Problem
A 3M REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER UPON REMOVING THE 3M¿ SPOTON¿ TEMPERATURE MONITORING SYSTEM 37000 SENSOR CABLE, THE SED LINE INDICATED A DEEPER LEVEL OF ANESTHESIA THAN WHEN THE TEMPERATURE MONITORING CABLE WAS APPLIED ALLEGING INTERFERENCE. AN UNSPECIFIED DOSAGE OF NARCAN WAS PROVIDED TO THE PATIENT DUE TO HIGHER LEVEL OF ADMINISTERED ANESTHESIA. NO FURTHER INTERVENTIONS WERE REPORTED FOR THE PATIENT.
Patient problems: Oversedation
MAUDE report 18048117 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.