MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-03 for SOMNO STAR & SERIES SLEEP SYSTEM 41 SOMNOSTAR Z4 V10 34133 manufactured by Carefusion, Inc.
[52128304]
(b)(4). All received components were returned to carefusion and forwarded to the supplier for an evaluation. Per the supplier, evaluation is not possible due to the control and power terminal blocks inside of the camera housing were not returned so the necessary parts to test the camera are not available.
Patient Sequence No: 1, Text Type: N, H10
[52128505]
The customer reported the camera is making a loud buzzing, moving back and forth in an attempt to focus, and is very hot to touch. Replacement was forwarded to the customer. There was no patient involvement, no harm to a user, and no property damage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031702-2016-00807 |
| MDR Report Key | 5845515 |
| Date Received | 2016-08-03 |
| Date of Report | 2016-07-09 |
| Date of Event | 2015-07-09 |
| Date Mfgr Received | 2015-07-09 |
| Date Added to Maude | 2016-08-03 |
| 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 | JILL RITTORNO |
| Manufacturer Street | 22745 SAVI RANCH PARKWAY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer Phone | 7149227830 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | 1100 BIRD CENTER DRIVE |
| Manufacturer City | PALM SPRINGS CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SOMNO STAR & SERIES SLEEP SYSTEM |
| Generic Name | STANDARD POLYSOMNOGRAPH WITH ELECTROENCEPHALOGRAPH |
| Product Code | OLV |
| Date Received | 2016-08-03 |
| Returned To Mfg | 2015-11-19 |
| Model Number | 41 SOMNOSTAR Z4 V10 |
| Catalog Number | 34133 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 22745 SAVI RANCH PKWY YORBA LINDA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-03 |