MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-26 for T.OX SP SENSOR OXY-2-SPD-1 manufactured by Vioptix, Inc..
[185013960]
Not responding when correctly placed on tissue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9882588 |
| MDR Report Key | 9882588 |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-03-09 |
| Report Date | 2020-03-13 |
| Date Reported to FDA | 2020-03-13 |
| Date Reported to Mfgr | 2020-03-26 |
| Date Added to Maude | 2020-03-26 |
| 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 |
| 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 | T.OX SP SENSOR |
| Generic Name | OXIMETER, TISSUE SATURATION |
| Product Code | MUD |
| Date Received | 2020-03-26 |
| Model Number | OXY-2-SPD-1 |
| Catalog Number | OXY-2-SPD-1 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VIOPTIX, INC. |
| Manufacturer Address | 39655 EUREKA DRIVE NEWARK CA 94560 US 94560 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |