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DeRoyal 81-050409Recalls & reported problems

Deroyal Industries, Inc. · Esophageal Stethoscope w/Temperature Sensor · 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 00749756045964), received between Jul 6, 2021 and Jul 6, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “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.

Most reported problems

Device problems

  • Compatibility Problem1
  • Sensing Intermittently1

Patient problems

  • Alteration in Body Temperature1

Recent adverse event reports

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

  • MalfunctionJul 6, 2021Sensing Intermittently; Compatibility Problem; Sensing Intermittently; Compatibility Problem

    PATIENT REACHED APPROPRIATE RANGE (36.5-37.0 DEGREES CELSIUS AT APPROXIMATELY 1815 HOURS. AT APPROXIMATELY 1850 HOURS, ESOPHAGEAL TEMPERATURE READING PER BLANKETROL WAS READING 33.1 DEGREES CELSIUS. PER BLACK MARKING ON ESOPHAGEAL PROBE, PROBE DID NOT BECOME DISLODGED OR MOVE. AXILLARY TEMPERATURE 37.8 DEGREES CELSIUS AND 37.8 DEGREES CELSIUS RECTAL TEMPERATURE.

    Patient problems: Alteration in Body Temperature

    MAUDE report 12120705 ↗

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