MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L GENERAL PURPOSE PROBE, 400 SERIES 9 FR (+/-0.2); THERMOMETER, ELECTRONIC, CLINICAL

Model Number	M1024229VY
Medical Device Problem Codes	Incorrect Interpretation of Signal (1543); Increased Sensitivity (2535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported "the temperature probe is not showing the right temperature and is very sensitive when moving the probe.".
Additional Manufacturer Narrative
A user facility reported, "temperature probe is not showing the right temperature and very sensitive when moving the probe." the sample was requested from vyaire, but it could not be returned.Because no sample could be returned, functional testing could not be performed on the defective sample.Deroyal industries reviewed 200 work orders, the failure modes and effects analysis (fmea), and the device history record and no issues were found.An inventory check was performed on 125 probes and all were found to be acceptable.(b)(4).Root cause: because a functional inspection could not be performed on the defective sample and no issues were identified in documentation on hand, no root cause can be determined.Corrective and preventive action: because no root cause could be determined, deroyal has not taken any corrective or preventive actions.Deroyal will continue to monitor for trends surrounding 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 more information becomes available.

• Brand Name: GENERAL PURPOSE PROBE, 400 SERIES 9 FR (+/-0.2)
• 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: 19950071
• Report Number: 9613793-2023-00015
• Device Sequence Number: 15694890
• Product Code: FLL
• UDI-Device Identifier: 00749756984072
• UDI-Public: 00749756984072
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 07/25/2023

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
• Device Model Number: M1024229VY
• Device Lot Number: 58173385
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 08/09/2024
• 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