MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-06-28 for ESOPHAGEAL STETHOSCOPE 81-040418 manufactured by Deroyal Cientifica De Latinoamerica S.r.l..
[112567957]
Root cause: after investigation, the root cause was unable to be determined since an analysis of the defective sample could not be performed. Additionally, a lot number for the defective product was not provided, and a review of documentation on hand found no issues that may have contributed to the reported event. Corrective action: a corrective action was not taken due to the root cause determination. Investigation summary. An internal complaint (call 44290) was received indicating an esophageal stethoscope (part (b)(4), lot not provided) provided unstable temperature readings during a procedure. The defective sample was not available for return. Additionally, the lot number of the defective device was not provided; therefore, a review of the device history record could not be performed. An inventory check of work order in process was performed and no issues were detected from a functional standpoint. All results were within the specification. A review of the last two manufactured and closed work orders was performed. No issues were found. The last two years of complaints were reviewed for similar reported events of unstable temperature readings. A total of 8 similar complaints were identified for the temperature monitoring probe product group. However, only one complaint (call 42523) was for the same part number under investigation. Call 42523 has been closed and the root cause was determined to be a manufacturing defect. Preventive action: a preventive action has not been taken due to the root cause determination. The investigation is complete at this time. If and when critical information is received, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[112567958]
During procedure, the physician requested reading of temperature probe. A nurse stated that numbers were fluctuating and not dependable. Probe was withdrawn and new probe inserted with no issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9613793-2018-00002 |
| MDR Report Key | 7645110 |
| Report Source | USER FACILITY |
| Date Received | 2018-06-28 |
| Date of Report | 2018-06-25 |
| Date of Event | 2018-05-16 |
| Date Mfgr Received | 2018-05-30 |
| Date Added to Maude | 2018-06-28 |
| 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 |
| Generic Name | STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS |
| Product Code | BZT |
| Date Received | 2018-06-28 |
| Model Number | 81-040418 |
| Lot Number | NOT PROVIDED |
| 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 | 2018-06-28 |