MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L ESOPH STETH 400 SERIES 18 FR, 400 SERIES = 2 PRONGS; STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS

Model Number	81-040418
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A distributing facility reported, "sensor malfunction.The machine could not read the temperature." deroyal industries requested return of the sample, however, it has not yet been returned.Deroyal reviewed work orders and failure mode and effects analysis (fmeas) and no issues were found.An inventory check was completed on 125 esophageal stethoscopes and all were within specification.A complaint to sales ratio was calculated and was found to be (b)(4).Root cause: because the device was not returned and no issues or discrepancies were identified with product records, the root cause could not be determined.Corrective and preventive actions: because no root cause was determined, no corrective or preventive actions were taken.Deroyal will continue to monitor for trends around this issue and item.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 distributing facility reported, "sensor malfunction.The machine could not read the temperature.".

• Brand Name: ESOPH STETH 400 SERIES 18 FR, 400 SERIES = 2 PRONGS
• Common Device Name: STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS
• 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: 19951451
• Report Number: 9613793-2023-00018
• Device Sequence Number: 8801640
• Product Code: BZT
• UDI-Device Identifier: 00749756045988
• UDI-Public: 00749756045988
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K193027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/28/2023

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
• Operator of Device: Health Professional
• Device Model Number: 81-040418
• Device Lot Number: 56992951
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• 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