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

Model Number 81-040418

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

Patient Problem Alteration In Body Temperature (2682)

Event Date 11/02/2017

Event Type  malfunction  

Manufacturer Narrative

Root cause: a root cause could not be identified due to the absence of a defective sample for testing.If a defective sample is received, this complaint investigation will be reopened.Corrective action: a corrective action has not been taken due to the root cause determination.Investigation summary: an internal complaint (call (b)(4)) was received indicating that an esophageal stethoscope (finished good 81-040418, lot 42823110) was detecting inconsistent temperature values, which the end user reported posed a safety concern to patients.A defective sample was initially reported to be available for evaluation.As of the date of this report, a sample has not been returned to the manufacturing facility.The work order for the reported lot number was reviewed for discrepancies that may have contributed to the reported event.No discrepancies were identified.Functional results for all sub-assembly work orders were reviewed and all were found to be within specification.A two-year review of complaints for the reported finished good were reviewed.No similar issues have been reported during that time period.A functional inspection of material in process was conducted.All results were within specification.Preventive action: a preventive action has not been taken due to the root cause determination.The investigation is complete at this time.If new and critical information is received, this report will be updated.

Event Description

The esophageal stethoscopes recently have been displaying inconsistent values, which the end user states is a safety concern for patients.In one instance, one of the probes had been reading a temperature of 36, while the oral thermometer comparison was reading >38 degrees.The patient's body was actually extremely warm.In other instances, a significant drop in body temperature had been noted during bolus feedings.

• Brand Name: ESOPHAGEAL STETHOSCOPE
• 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: 7076510
• MDR Text Key: 94544272
• Report Number: 9613793-2017-00007
• Device Sequence Number: 1
• Product Code: BZT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 81-040418
• Device Lot Number: 42823110
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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