MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L. ESOPHAGEAL STETHOSCOPE, 12 FRENCH; STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS

Model Number	81-040412
Medical Device Problem Codes	Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause: a root cause could not be determined.No issues were identified with the defective unit, and no issues were found during review of quality documentation.Corrective action: due to the root cause determination, no corrective actions were taken.Investigation summary: an internal complaint (call 48373) was received indicating an esophageal stethoscope (part 81-040412, lot 49586751) failed during use.Specifically, the temperature reading was stuck at 28.3 degrees celsius.The defective sample was returned for evaluation and functionally tested.The unit was tested in three thermal baths at 37 degrees celsius.In each bath, the resistance was measured at 1358 ohms, which indicates the device was within specification.The device history record for the reported lot was reviewed for discrepancies that may have contributed to the reported event.No discrepancies were identified.Product in-process was functionally inspected and all units were found to be in tolerance.Finished good product on hand was visually inspected and no issues were found.The last two years of the complaint log were reviewed, and four reports were identified as being generated due to a functional issue.All four complaints were investigated and verified.The investigation is complete at this time.If new and critical information becomes available, this report will be updated.
Event or Problem Description
The temperature reading was stuck at 28.3 degrees celsius.This occurred during use.

• Brand Name: ESOPHAGEAL STETHOSCOPE, 12 FRENCH
• Common Device Name: STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS
• Manufacturer (Section D): DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L.; global park; box 180-3006, 602 parkway; la aurora, heredia, heredia 146 ; CS 146
• MDR Report Key: 9284261
• Report Number: 9613793-2019-00004
• Device Sequence Number: 10800755
• Product Code: BZT
• UDI-Device Identifier: 00749756045995
• UDI-Public: 00749756045995
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K925789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/06/2019

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: 81-040412
• Device Lot Number: 49586751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1