MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-05-07 for ESOPHAGEAL STETHOSCOPE, SOFT TUBE, 400 SERIES 81-050418 manufactured by Deroyal Cientifica De Latinoamerica Sa.
[5794091]
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.
Patient Sequence No: 1, Text Type: D, B5
[13379953]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9613793-2015-00009 |
| MDR Report Key | 4759428 |
| Report Source | 06 |
| Date Received | 2015-05-07 |
| Date of Report | 2015-05-05 |
| Date of Event | 2015-04-06 |
| Date Facility Aware | 2015-04-06 |
| Report Date | 2015-05-05 |
| Date Mfgr Received | 2015-04-06 |
| Date Added to Maude | 2015-06-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653626112 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESOPHAGEAL STETHOSCOPE, SOFT TUBE, 400 SERIES |
| Generic Name | STETHOSCOPE, ESOPHAGEAL |
| Product Code | BZT |
| Date Received | 2015-05-07 |
| Catalog Number | 81-050418 |
| Lot Number | 36156293 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL CIENTIFICA DE LATINOAMERICA SA |
| Manufacturer Address | 602 PARKWAY, P.O. BOX 180-3006 GLOBAL PARK LA AURORA, HEREDIA 146 CS 146 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-07 |