GENERAL PURPOSE PROBE, 400 SERIES9 FR/APP29"L/1/2"DIA
Received Mar 9, 2026 · Event occurred Feb 1, 2026
Report 9613793-2026-00007 · MDR key 24548589
Device
Generic name
Continuous Measurement Thermometer
Manufacturer
Deroyal Cientifica De Latinoamerica S.r.lModel number
81-020409Lot number
62530402
Product problems
- Failure to Sense
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A USER FACILITY REPORTED THROUGH A MEDWATCH, "ESOPHAGEAL TEMP PROBE PLACED FOR CORE TEMP MONITORING WITH WHOLE BODY COOLING PROTOCOL. PLUGGED ESOPHAGEAL TEMP PROBE INTO CORD CONNECTED TO BLANKETEROL AND THE MACHINE DID NOT RECOGNIZE A TEMPERATURE AND ALARMED CHECK PROBE. BLANKETEROL TEMP CORD PLUGGED INTO RECTAL TEMP PROBE AND WORKED. AFTER CONFIRMING THAT THE CORD FROM THE BLANKETEROL WAS WORKING TRIED TO USE WITH ESOPHAGEAL TEMP PROBE AGAIN BUT IT WOULD NOT READ A TEMPERATURE. REMOVED ESOPHAGEAL PROBE AND PLACED A NEW ONE. NEW ESOPHAGEAL PROBE READING WITHOUT ISSUE." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, HOWEVER, IT WAS STATED THAT IT WAS UNAVAILABLE FOR RETURN. THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW UP REPORT WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
A USER FACILITY REPORTED VIA A MEDWATCH, "ESOPHAGEAL TEMP PROBE PLACED FOR CORE TEMP MONITORING WITH WHOLE BODY COOLING PROTOCOL. PLUGGED ESOPHAGEAL TEMP PROBE INTO CORD CONNECTED TO BLANKETEROL AND THE MACHINE DID NOT RECOGNIZE A TEMPERATURE AND ALARMED CHECK PROBE. BLANKETEROL TEMP CORD PLUGGED INTO RECTAL TEMP PROBE AND WORKED. AFTER CONFIRMING THAT THE CORD FROM THE BLANKETEROL WAS WORKING TRIED TO USE WITH ESOPHAGEAL TEMP PROBE AGAIN BUT IT WOULD NOT READ A TEMPERATURE. REMOVED ESOPHAGEAL PROBE AND PLACED A NEW ONE. NEW ESOPHAGEAL PROBE READING WITHOUT ISSUE."