MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-12-09 for NONIN MODEL 8604-D-L PULSE OXIMETER 8604D-L manufactured by Nonin Medical.
[15754]
See referenced report # 36222-1994-9001. Same event description.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 36222-1994-09004 |
| MDR Report Key | 23467 |
| Date Received | 1994-12-09 |
| Date of Report | 1994-10-26 |
| Date of Event | 1994-10-17 |
| Date Facility Aware | 1994-10-18 |
| Report Date | 1994-10-26 |
| Date Reported to FDA | 1994-10-26 |
| Date Reported to Mfgr | 1994-10-26 |
| Date Added to Maude | 1995-07-14 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | NONIN MODEL 8604-D-L PULSE OXIMETER |
| Generic Name | OXIMETER |
| Product Code | KLK |
| Date Received | 1994-12-09 |
| Model Number | 8604D-L |
| Catalog Number | NI |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 5.5 YR |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 23750 |
| Manufacturer | NONIN MEDICAL |
| Manufacturer Address | 12900 HIGHWAY 55 PLYMOUTH MN 55441 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1994-12-09 |