MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA SA ESOPHAGEAL STETHOSCOPE, SOFT TUBE, 400 SERIES; STETHOSCOPE, ESOPHAGEAL

Catalog Number 81-050418

Device Problems Electrical /Electronic Property Problem (1198); Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/06/2015

Event Type  malfunction  

Event Description

Dr (b)(6) had an esophageal probe the other day that stopped working during a case.He saved packaging, not product: ref# 81-050418, lot 36156293.He played with the cable and replaced cable with no improvement.He then just replaced catheter and it worked fine until completed.The temperature probe was connected to the cable that was then connected to the anesthesia machine.

Manufacturer Narrative

Investigation findings: no additional inspections were performed to the defective unit since it was not available.Dhr of sub-assembled wo was reviewed and it was determined that no discrepancies or non-conformance reports were found during the manufacturing process of the product.Complaints log was reviewed and it was confirmed that no additional issues of this product (81-050418) have been reported.Manufacturing procedure dcla.Mfg.013 (testing procedure, rev d) was reviewed and it was confirmed that it states: "906 proceed to inspect the resistance of the thermistors ensuring that the obtained reading in the tester, do match with the required reading as established within dcla.Frm.046 (resistance specifications for testing of thermistors.If the tester is showing a zero value, it means that the unit has a short circuit; this unit shall be placed in the required section of the rack.If the tester is showing an ol reading, it means that the unit has an open circuit; this unit shall be placed in the required section of the rack.If any other defect is found, place the unit in the required section of the rack." acd.Fmea.060, rev c, was reviewed and it was determined that item #2 captures the reported failure mode: "temperature reading stops intra-operatively," considering as a failure cause, "loose wire connection" and as end effects: check connections and/or probe replacement, prolonged procedure due to replacement, possible additional anesthesia for patient and user dissatisfied.Correction: no corrections have been taken at this point.Root cause analysis: after investigation, it was not possible to determine a specific root cause of this issue due to the defective sample not being available for additional testing.So as per acd.Fema.060, rev c, item #2, a loose wire connection is the most possible cause.Corrective action and/or systemic correction action taken: no corrective actions will be taken due that there is not a determinate root cause.Preventive action: n/a.The investigation is complete at this time.This report will be updated as more information is available.

• Brand Name: ESOPHAGEAL STETHOSCOPE, SOFT TUBE, 400 SERIES
• Type of Device: STETHOSCOPE, ESOPHAGEAL
• Manufacturer (Section D): DEROYAL CIENTIFICA DE LATINOAMERICA SA; 602 parkway, p.o. box 180-3006; global park; la aurora, heredia 146 ; CS 146
• Manufacturer Contact: 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 4759428
• MDR Text Key: 5794091
• Report Number: 9613793-2015-00009
• 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: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 81-050418
• Device Lot Number: 36156293
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/06/2015
• Event Location: Hospital
• Date Manufacturer Received: 04/06/2015
• 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