MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-09 for SOMNOSTAR manufactured by Carefusion 207, Inc. Dba Carefusion.
[59514637]
Patient Sequence No: 1, Text Type: N, H10
[59514638]
The headbox was not functioning properly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6090201 |
| MDR Report Key | 6090201 |
| Date Received | 2016-11-09 |
| Date of Report | 2016-09-30 |
| Date of Event | 2016-04-11 |
| Report Date | 2016-09-30 |
| Date Reported to FDA | 2016-09-30 |
| Date Reported to Mfgr | 2016-09-30 |
| Date Added to Maude | 2016-11-09 |
| 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 |
| 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 | SOMNOSTAR |
| Generic Name | ELECTROENCEPHALOGRAPH |
| Product Code | OLV |
| Date Received | 2016-11-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION 207, INC. DBA CAREFUSION |
| Manufacturer Address | 22745 SAVI RANCH PARKWAY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-09 |