MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-03-05 for NOVATEMP C-400 SERIES 9FR 10-1610-160 manufactured by Novamedusa.
[4341455]
During a surgical procedure in an or, the patient's temp readings were drifting in excess of 2. 5 degrees. It was found to be a failure of the temp probe. Upon our investigation, we found that it had happened at least four times prior to this documented event with different anesthesiologists.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3672177 |
| MDR Report Key | 3672177 |
| Date Received | 2014-03-05 |
| Date of Report | 2014-03-05 |
| Date of Event | 2013-12-10 |
| Report Date | 2014-03-05 |
| Date Reported to FDA | 2014-03-05 |
| Date Reported to Mfgr | 2014-03-11 |
| Date Added to Maude | 2014-03-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOVATEMP C-400 SERIES |
| Generic Name | ACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS, TEMPERATURE PRO |
| Product Code | KRI |
| Date Received | 2014-03-05 |
| Returned To Mfg | 2013-12-20 |
| Model Number | 9FR |
| Catalog Number | 10-1610-160 |
| Lot Number | 131163101 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOVAMEDUSA |
| Manufacturer Address | 4 WESTCHESTER PLAZA ELMSFORD NY 10523 US 10523 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-05 |