MAUDE Adverse Event Report: ESOPHAGEAL STETHOSCOPE SOFT TUBE WITH TEMPERATURE SENSOR

Model Number	81-050409
Medical Device Problem Codes	Sensing Intermittently (1558); Compatibility Problem (2960)
Health Effect - Clinical Code	Alteration in Body Temperature (4568)
Date of Event	06/08/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: ESOPHAGEAL STETHOSCOPE
• MDR Report Key: 12120705
• Report Number: 9613793-2021-00014
• Device Sequence Number: 17347597
• Product Code: BZT
• UDI-Device Identifier: 00749756045964
• UDI-Public: 00749756045964
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K193027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/06/2021

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: 81-050409
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 07/06/2021
• 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