MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-27 for SOMNO STAR Z4 manufactured by Carefusion 207, Inc. Dba Carefusion.
[36913422]
Patient Sequence No: 1, Text Type: N, H10
[36913423]
In the "look back" feature the oxygen trend (spo2) reads 2 minutes in the future not at the 'current' window. There is no running spo2 trend while collecting data. It is necessary to know what the o2 desaturation is to determine the type and number of events. Patients need to meet a criterion before treatment can be started.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5392761 |
| MDR Report Key | 5392761 |
| Date Received | 2016-01-27 |
| Date of Report | 2016-01-05 |
| Date of Event | 2015-11-05 |
| Report Date | 2015-11-17 |
| Date Reported to FDA | 2015-11-17 |
| Date Reported to Mfgr | 2015-11-17 |
| Date Added to Maude | 2016-01-27 |
| 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 | 0 |
| 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 | SOMNO STAR |
| Generic Name | STANDARD POLYSOMNOGRAPHY WITH ELECTROENCEPHALOGRAPH |
| Product Code | OLV |
| Date Received | 2016-01-27 |
| Model Number | Z4 |
| ID Number | VER. 10 |
| Device Availability | Y |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION 207, INC. DBA CAREFUSION |
| Manufacturer Address | 1100 BIRD CENTER DR. PALM SPRINGS CA 92262 US 92262 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-27 |