MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-23 for STRYKER NEPTUNE 3 ROVER 0703001000 0703-001-0003 manufactured by Stryker Corporation.
[142745950]
Around 1450 a staff member called the charge nurse regarding the surgeon's concern of a smoke smell from the or room. I went in the room and smelled smoke from the right bottom corner of the room coming from the hallway. I informed the charge nurse and instructed her to activate a fire code. Patient was draped but no incision was made yet. The back table, mayo stand and patient's covered with drape. The surgeon told me that the odor that it was coming from the trashbag. I took the trashbag from the room and opened it but did not smell anything. I also took the hovermat machine outside the room and did not smell anything from it either. Another team member walked in and figured that the neptune machine was creating the smoke smell. The machine was unplugged. Fire marshall and fire safety walked in the room and was informed about the neptune machine. Neptune machine given to clinical engineering. Stryker neptune 3 rover ref 0703-001-000; sn (b)(4). Device had passed pm's approximately 2 months ago.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8539297 |
| MDR Report Key | 8539297 |
| Date Received | 2019-04-23 |
| Date of Report | 2019-04-10 |
| Date of Event | 2019-04-08 |
| Report Date | 2019-04-10 |
| Date Reported to FDA | 2019-04-10 |
| Date Reported to Mfgr | 2019-04-23 |
| Date Added to Maude | 2019-04-23 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRYKER NEPTUNE 3 ROVER |
| Generic Name | APPARATUS, SUCTION, AND EXHAUST |
| Product Code | FYD |
| Date Received | 2019-04-23 |
| Model Number | 0703001000 |
| Catalog Number | 0703-001-0003 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER CORPORATION |
| Manufacturer Address | 4100 EAST MILHAM AVE. KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-23 |