MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-12-06 for * 81-040418 manufactured by Deroyal.
[4114545]
The patient was having spine surgery and a esophageal temperature probe was being used. During the operation the patient's temperature was noted to be 39. 3. There were no vital sign changes and the patient did not appear to have a fever. An arterial line was placed and labs were drawn. It was finally determined that the temperature probe had malfunctioned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3532638 |
| MDR Report Key | 3532638 |
| Date Received | 2013-12-06 |
| Date of Report | 2013-12-06 |
| Date of Event | 2013-12-04 |
| Report Date | 2013-12-06 |
| Date Reported to FDA | 2013-12-06 |
| Date Reported to Mfgr | 2013-12-23 |
| Date Added to Maude | 2013-12-23 |
| 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 | 0 |
| 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 | * |
| Generic Name | STETHOSCOPE, ESOPHAGEAL |
| Product Code | BZT |
| Date Received | 2013-12-06 |
| Model Number | 81-040418 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL |
| Manufacturer Address | 200 DEBUSK LANE POWELL TN 37849 US 37849 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-06 |