Mon-a-Therm 502-0401ARecalls & reported problems
Covidien LP · Cable 400TM;For HP (TM) or Philips (TM) Monitors HP and Philips are trademarks of their respective owners. · Class 2
All models of Mon-a-Therm (12)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 10884521169289), received between Dec 6, 2022 and Dec 6, 2022 — classified as 1 injury.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- High Readings1
Patient problems
- Hypothermia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 6, 2022High Readings; High Readings
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PATIENT WAS SEDATED AND WAS INSERTED WITH URINE CATHETER AND THE CABLE WAS CONNECTED. THE PATIENT'S TEMPERATURE WAS MONITORED USING THE DEVICE WITH 39.1°C AT 08:52 AM, AND 40.4°C AT 09:03 AM. THE HEALTH CARE PROVIDED (HCP) STARTED HYPOTHERMIC TREATMENT IN ORDER TO LOWER THE PATIENT'S TEMPERATURE, COOL THE PATIENT AND GAVE MEDICATION FOR FEVER. AFTER 30 MINUTES, THE PATIENT STILL HAD 40.4C FEVER. THE SURGERY WAS SET ON PAUSE AND THE COVERS WERE REMOVED, THE HCP REALIZED THAT THE PATIENT WAS NOT WARM AND DID NOT HAVE FEVER. THE RECTAL TEMPERATURE WAS MEASURED AND CHANGED TO A NEW CATHETER, THE TEMPERATURE SHOWED 35.0°C AT 9:28 AM. THE BABY WAS UNNECESSARILY COOLED AND THE SURGERY WAS ALMOST CANCELLED.
Patient problems: Hypothermia
MAUDE report 15923784 ↗
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- Medline MDSTH1002Medline Industries, Inc. · Thermometer, electronic, clinical65 reports
- Mon-a-Therm 90050Covidien LP · Thermometer, electronic, clinical1 recall3 reports
- Mon-a-Therm 90044Covidien LP · Thermometer, electronic, clinical1 recall2 reports
- CARESCAPE B450 MBA313GE Healthcare Finland Oy · Thermometer, electronic, clinical1 recall1 report
- Temperature Probes Esophageal/Rectal Temperature ProbePhilips Medical Systems Hsg · Thermometer, electronic, clinical1 recall1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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