MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-01 for ESOPHAGEAL STETHOSCOPE 81-040418 manufactured by Deroyal Cientifica De Latinoamerica S.r.l..
[94544272]
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.
Patient Sequence No: 1, Text Type: N, H10
[94544273]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9613793-2017-00007 |
| MDR Report Key | 7076510 |
| Date Received | 2017-12-01 |
| Date of Report | 2017-12-01 |
| Date of Event | 2017-11-02 |
| Date Mfgr Received | 2017-11-03 |
| Date Added to Maude | 2017-12-01 |
| 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 | 0 |
| Brand Name | ESOPHAGEAL STETHOSCOPE |
| Generic Name | STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS |
| Product Code | BZT |
| Date Received | 2017-12-01 |
| Model Number | 81-040418 |
| Lot Number | 42823110 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-12-01 |