MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-04 for NONIN 8004CB manufactured by Nonin Medical, Inc..
| Report Number | 2183646-2019-00001 |
| MDR Report Key | 9276238 |
| Date Received | 2019-11-04 |
| Date of Report | 2019-10-10 |
| Date of Event | 2019-05-20 |
| Date Added to Maude | 2019-11-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. WALTER HOLBEIN |
| Manufacturer Street | 13700 1ST AVE. NORTH |
| Manufacturer City | PLYMOUTH MN 554415443 |
| Manufacturer Country | US |
| Manufacturer Postal | 554415443 |
| Manufacturer Phone | 7635775504 |
| Manufacturer G1 | NONIN MEDICAL, INC. |
| Manufacturer Street | 13700 1ST AVE., NORTH |
| Manufacturer City | PLYMOUTH MN 554415443 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 554415443 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NONIN 8004CB |
| Generic Name | OXIMETER, TISSUE SATURATION |
| Product Code | MUD |
| Date Received | 2019-11-04 |
| Returned To Mfg | 2019-10-09 |
| Model Number | 8004CB |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NONIN MEDICAL, INC. |
| Manufacturer Address | 13700 1ST AVE., NORTH PLYMOUTH MN 554415443 US 554415443 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-11-04 |