MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-03-05 for STANDARD POLYSOMNOGRAPH WITH ELECTROENCEPHALOGRAPH SOMNOSTAR Z4 SYSTEM VER 10 23586-001 manufactured by Vyaire Medical, Inc.
[101511998]
Vyaire identifier: (b)(4). The suspect component has been returned to vyaire and further evaluation is pending. Upon completion of the final evaluation, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[101511999]
The customer reported while using the somnostar device, the monitor will not maintain a picture and it gave him (the user of the device) an electrical shock feeling. The user reported that there was no harm or injury, and no medical intervention was sought. The customer stated there was no patient involvement associated with this reported event.
Patient Sequence No: 1, Text Type: D, B5
[114592643]
The vyaire medical failure analysis laboratory received the suspect component, a dell flat panel monitor, and evaluated the component. An evaluation of the component duplicated the reported issue and found that the part is nonfunctional, but there is no occurrence of electrical shock.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021710-2018-07474 |
| MDR Report Key | 7313311 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-03-05 |
| Date of Report | 2018-03-20 |
| Date of Event | 2018-02-07 |
| Date Mfgr Received | 2018-03-08 |
| Device Manufacturer Date | 2015-07-01 |
| Date Added to Maude | 2018-03-05 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KRISTIN GRAF |
| Manufacturer Street | 22745 SAVI RANCH PARKWAY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer G1 | VYAIRE MEDICAL, INC |
| Manufacturer Street | 1100 BIRD CENTER DR. |
| Manufacturer City | PALM SPRINGS CA 92262 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92262 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STANDARD POLYSOMNOGRAPH WITH ELECTROENCEPHALOGRAPH |
| Generic Name | SOMNO STAR & SERIES SLEEP SYSTEM |
| Product Code | OLV |
| Date Received | 2018-03-05 |
| Returned To Mfg | 2018-03-01 |
| Model Number | SOMNOSTAR Z4 SYSTEM VER 10 |
| Catalog Number | 23586-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL, INC |
| Manufacturer Address | 22745 SAVI RANCH PARKWAY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-05 |