MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L NASOPHARYNGEAL TEMPERATURE PRO, 9 FR, 18" TUBE / TWISTED CORD; THERMOMETER, ELECTRONIC, CLINICAL

Model Number	81-025409
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported, "arctic sun communicating "pt measurement erratic.Therapy stopped." after esophageal temps read a large range of values in a short period of time, causing the water temp to be 19-36 degrees in a short period of time.Vendor support contacted and suggested a short in the probe as the cause." this complaint was also reported to the fda with medwatch (b)(4).The device was not able for return.Deroyal industries reviewed the device history record with the work order, failure mode and effect analysis (fmea), and function results reviewed within.No issues were found with the manufacturing process.Previous material review reports as well as product in process were reviewed and no similar issues were found.A complaint to sales ratio was conducted over the past two years and found to be (b)(4).Root cause: because no sample was available for return and no issues were found within the manufacturing review, the issue could not be recreated and therefore no root cause was able to be established.Corrective or preventive actions: because no root cause was determined, no corrective or preventive actions were taken.Deroyal will continue to monitor for trends around this item and issue.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.
Event or Problem Description
A user facility reported, "arctic sun communicating "pt measurement erratic.Therapy stopped." after esophageal temps read a large range of values in a short period of time, causing the water temp to be 19-36 degrees in a short period of time.Vendor support contacted and suggested a short in the probe as the cause".

• Brand Name: NASOPHARYNGEAL TEMPERATURE PRO, 9 FR, 18" TUBE / TWISTED CORD
• Common Device Name: THERMOMETER, ELECTRONIC, CLINICAL
• 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 newman ; 200 debusk lane; powell, TN 37849
• MDR Report Key: 19960633
• Report Number: 9613793-2024-00002
• Device Sequence Number: 17912409
• Product Code: FLL
• UDI-Device Identifier: 00749756694841
• UDI-Public: 00749756694841
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K925791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2024

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: 81-025409
• Device Lot Number: 55907873
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 08/12/2024
• 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