MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-04-10 for ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR 81-040412 manufactured by Deroyal Cientifica De Latinoamerica S.r.l..
[146657064]
Root cause: a root cause could not be determined. The defective sample was not returned for evaluation, and no issues were identified during a review of quality records. Corrective action: due to the root cause determination, a corrective action has not been taken. Investigative summary: an internal complaint (call (b)(4)) was received indicating an esophageal stethoscope with temperature sensor (part 81-040412, lot 48181841) stopped detecting temperature during use, and a skin probe had to be pulled to continue monitoring the patient's temperature. The defective sample was unavailable for return. Therefore, a functional inspection could not be performed. The initial report indicated representative samples from the same lot were available for return. However, as of the date of this report, those samples have not been returned to the manufacturer for evaluation. The device history record (dhr) was reviewed for the reported lot number and no issues were reported during the manufacturing or inspection of the product. The bill of material for the work order involved was reviewed to identify the sub-assembly wire set used to manufacture the lot. The functional results for this sub-assembly (lot 48242691) were reviewed and no discrepancies were reported during the quality inspection. A functional inspection of product in process was made. One-hundred and twenty-five samples from work order 48229429 were inspected and all units were found within tolerance. The 2017-2019 complaint log was reviewed for similar complaints. Two complaints ((b)(4)) were identified for an esophageal stethoscope displaying inconsistent temperature readings. At this time, these complaints have been closed and verified. The investigation is complete at this time. If new and critical information is received, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[146657065]
During a dental case, the esophageal stethoscope with temperature sensor stopped reading the patient's temperature. A skin probe was pulled to the patient's temperature could continue being monitored.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9613793-2019-00002 |
| MDR Report Key | 8500822 |
| Report Source | USER FACILITY |
| Date Received | 2019-04-10 |
| Date of Report | 2019-04-10 |
| Date of Event | 2019-03-07 |
| Date Mfgr Received | 2019-03-11 |
| Date Added to Maude | 2019-04-10 |
| 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 Contact | SARAH BENNETT |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653626112 |
| Manufacturer G1 | DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L. |
| Manufacturer Street | GLOBAL PARK BOX 180-3006, 602 PARKWAY |
| Manufacturer City | LA AURORA, HEREDIA, HEREDIA 146 |
| Manufacturer Country | CS |
| Manufacturer Postal Code | 146 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR |
| Generic Name | STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS |
| Product Code | BZT |
| Date Received | 2019-04-10 |
| Model Number | 81-040412 |
| Lot Number | 48181841 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L. |
| Manufacturer Address | GLOBAL PARK BOX 180-3006, 602 PARKWAY LA AURORA, HEREDIA, HEREDIA 146 CS 146 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-10 |