MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L ESOPHAGEAL STETHOSCOPE SOFT TUBE WITH TEMPERATURE SENSOR

Model Number 81-050409

Device Problems Sensing Intermittently (1558); Compatibility Problem (2960)

Patient Problem Alteration in Body Temperature (4568)

Event Date 06/08/2021

Event Type  malfunction  

Manufacturer Narrative

Root cause was undetermined.Defective sample was to be received; however, the device was not located by the customer; therefore, it was not possible to perform further inspection.Failure mode effective analysis (fmea) on file was reviewed and it was confirmed that there is already a failure mode identified related to the issue under investigation, and controls have been implemented by the manufacturing plant's procedure in relation to quality inspection.Complaint log of the last two years was reviewed and it was confirmed that no similar issues of the same part number have been reported.According to the bill of material of the product involved, this finished good is used in a sub-assembly, material in process of this product was inspected, functional results ((b)(4)) of the work order were reviewed and it was confirmed that all results were found within the tolerance.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.

Event Description

Patient reached appropriate range (36.5-37.0 degrees celsius at approximately 1815 hours.At approximately 1850 hours, esophageal temperature reading per blanketrol was reading 33.1 degrees celsius.Per black marking on esophageal probe, probe did not become dislodged or move.Axillary temperature 37.8 degrees celsius and 37.8 degrees celsius rectal temperature.

• Brand Name: ESOPHAGEAL STETHOSCOPE SOFT TUBE WITH TEMPERATURE SENSOR
• Type of Device: ESOPHAGEAL STETHOSCOPE
• 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
• MDR Report Key: 12120705
• MDR Text Key: 265179129
• Report Number: 9613793-2021-00014
• Device Sequence Number: 1
• Product Code: BZT
• UDI-Device Identifier: 00749756045964
• UDI-Public: 00749756045964
• Combination Product (y/n): N
• PMA/PMN Number: K193027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 81-050409
• Date Manufacturer Received: 06/08/2021
• Was Device Evaluated by Manufacturer?: No
• 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