MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-07 for NELLCOR MAXNR manufactured by Covidien Lp.
[107474163]
Patient Sequence No: 1, Text Type: N, H10
[107474164]
New oximeter probe placed on patient. Light on probe was flashing and monitor read "needs new sensor. " this was a brand-new probe directly out of the package.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7490214 |
| MDR Report Key | 7490214 |
| Date Received | 2018-05-07 |
| Date of Report | 2018-04-24 |
| Date of Event | 2018-04-12 |
| Report Date | 2018-04-24 |
| Date Reported to FDA | 2018-04-24 |
| Date Reported to Mfgr | 2018-04-24 |
| Date Added to Maude | 2018-05-07 |
| 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 |
| 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 | NELLCOR |
| Generic Name | OXIMETER, REPROCESSED |
| Product Code | NLF |
| Date Received | 2018-05-07 |
| Model Number | MAXNR |
| Catalog Number | MAXNR |
| Lot Number | 180290068 |
| Operator | NURSE |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP |
| Manufacturer Address | 15 HAMPSHIRE ST MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-07 |