MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L SKIN TEMPERATURE PROBE, 400 SERIES; THERMOMETER, ELECTRONIC, CLINICAL

Model Number	81-010400
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported, " pre-op patient temp is taken manually.Intra-op patient temp is monitored by deroyal's skin temp sensor in axillary location, routinely off by 4 degrees.Post-op temp is taken manually." deroyal has requested return of a sample, but it has not yet been provided.The investigation is not complete at this time.No further information is available at this time.We will provide follow-up report once additional information becomes available.
Event or Problem Description
A user facility reported, " pre-op patient temp is taken manually.Intra-op patient temp is monitored by deroyal's skin temp sensor in axillary location, routinely off by 4 degrees.Post-op temp is taken manually.".
Additional Manufacturer Narrative
A user facility reported, " pre-op patient temp is taken manually.Intra-op patient temp is monitored by deroyal's skin temp sensor in axillary location, routinely off by 4 degrees.Post-op temp is taken manually." deroyal requested return of a sample and received it on may 11, 2024.The sample was tested according to the specifications and confirmed to be within the designated specs.The device history record for the device was reviewed and it was confirmed that no issues were noted in manufacturing or inspection.Subassembly lots of the device were also reviewed and no functional issues were found.Inventory of 125 eaches were inspected and no functional issues were identified.Risk documents and material review reports were reviewed and did not require any updates or additions.(b)(4).Root cause: because no issues were found with the returned sample or documentation of the manufacturing process, no root cause could be determined.Corrective and preventive action: because no root cause could be established, no corrective or preventive actions were taken.The 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.

• Brand Name: SKIN TEMPERATURE PROBE, 400 SERIES
• 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 ; 8653622106
• MDR Report Key: 19960641
• Report Number: 9613793-2024-00003
• Device Sequence Number: 7080391
• Product Code: FLL
• UDI-Device Identifier: 00749756046169
• UDI-Public: 00749756046169
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 07/08/2024

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: 81-010400
• Device Lot Number: 60393328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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