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Mon-a-Therm 90041Recalls & reported problems

Covidien LP · Esophageal Stethoscope with Temperature Sensor 400TM · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20884521031712), received between Sep 13, 2022 and Sep 13, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “High Readings” (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

  • High Readings1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionSep 13, 2022High Readings; High Readings

    ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE DID NOT MEET THE EXPECTED RANGE REQUIREMENTS AS STATED IN THE PRODUCT INSTRUCTION FOR USE (IFU). THE EXPECTED READINGS WERE 35 TO 42 DEGREES CELSIUS. HOWEVER, THE PROBE READ HIGH BY 0.9C. THE TEST EQUIPMENT CALIBRATIONS WERE UP TO DATE AND REPEATED FOR SEVERAL TIMES WITH THE SAME RESULTS. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15412237 ↗

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