MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L GENERAL PURPOSE PROBE, 400 SERIES9 FR/APP29"L/1/2"DIA; CONTINUOUS MEASUREMENT THERMOMETER

Model Number	81-020409
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
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.".

• Brand Name: GENERAL PURPOSE PROBE, 400 SERIES9 FR/APP29"L/1/2"DIA
• Common Device Name: CONTINUOUS MEASUREMENT THERMOMETER
• Manufacturer (Section D): DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L; global park, p.o. box 180-3006; 602 parkway,; la aurora, heredia 146 ; CS 146
• Manufacturer (Section G): DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L; global park, p.o. box 180-3006; 602 parkway,; la aurora, heredia 146 ; CS 146
• Manufacturer Contact: reagan facemire ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 24548589
• Report Number: 9613793-2026-00007
• Device Sequence Number: 14846046
• Product Code: FLL
• UDI-Device Identifier: 00749756046145
• UDI-Public: 00749756046145
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K200631
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 81-020409
• Device Lot Number: 62530402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown