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

Model Number 81-040412

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/07/2019

Event Type  malfunction  

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 Description

The temperature reading was stuck at 28.3 degrees celsius.This occurred during use.

• Brand Name: ESOPHAGEAL STETHOSCOPE, 12 FRENCH
• Type of Device: 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
• Manufacturer (Section G): DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L.; global park; box 180-3006, 602 parkway; la aurora, heredia, heredia 146 ; CS 146
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 9284261
• MDR Text Key: 217698706
• Report Number: 9613793-2019-00004
• Device Sequence Number: 1
• Product Code: BZT
• UDI-Device Identifier: 00749756045995
• UDI-Public: 00749756045995
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K925789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1