DeRoyal 81-02S412Recalls & reported problems
Deroyal Industries, Inc. · General Purpose Temperature Probe, Soft · 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 00749756812573), received between Nov 15, 2019 and Aug 7, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Sense” (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
- Failure to Sense1
- Incorrect, Inadequate or Imprecise Result or Readings1
- Low Test Results1
- No Device Output1
- Output Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- 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 7, 2024No Device Output; Failure to Sense; No Device Output; Failure to Sense
TEMPERATURE SENSOR THAT HAS BEEN INSTALLED ON PATIENT (B)(6) ((B)(6)), DID NOT PERFORM READING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19928478 ↗MalfunctionNov 15, 2019Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Output Problem
THE PATIENT WAS AN INFANT USING A NEW RECTAL TEMPERATURE PROBE FOR MONITORING. THE TEMPERATURE WAS CONSISTENTLY READING LOW (35.3-35.7 C), SO PATIENT WAS PLACED ON A BAIR HUGGER. SUBSEQUENTLY, THE PATIENT'S BLOOD PRESSURE BECAME LOWER AND PERFUSION FELT ADEQUATE; HOWEVER, THE MONITOR STILL READ 35.6C. THE TEMPERATURE PROBE WAS SWITCHED WITH NO CHANGE IN TEMPERATURE ON MONITOR. THE PROBE AND CABLE WERE REPLACED, AND THE MONITOR READ 37.3 C, WHICH WAS MORE IN LINE WITH HOW THE PATIENT APPEARED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9327536 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.