MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-25 for STANDARD POLYSOMNOGRAPHY WITH ELECTROENCEPHALOGRAPH 41 SOMNOSTAR Z4 V9 16846 manufactured by Vyaire Medical Inc.
[134308173]
At this time, the suspect component has been received by vyaire and is awaiting evaluation. Once a final investigation has been completed, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[134308174]
The customer reported that the amplifier becomes very hot to touch. The device was in use on a patient at the time of the incident; however, there was no end user and patient harm associated with the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2019-08034 |
| MDR Report Key | 8279651 |
| Date Received | 2019-01-25 |
| Date of Report | 2018-03-26 |
| Date of Event | 2018-03-26 |
| Date Mfgr Received | 2018-03-26 |
| Device Manufacturer Date | 2008-12-12 |
| Date Added to Maude | 2019-01-25 |
| 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 | STANLEY TAN |
| Manufacturer Street | 22745 SAVI RANCH PARKWAY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer Phone | 7607787281 |
| Manufacturer G1 | DUCOMMUN LA BARGE |
| Manufacturer Street | 2222 EAST PENSAR DRIVE |
| Manufacturer City | APPLETON WI 549118789 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 549118789 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STANDARD POLYSOMNOGRAPHY WITH ELECTROENCEPHALOGRAPH |
| Generic Name | SOMNOSTAR & SERIES SLEEP SYTEM |
| Product Code | GWQ |
| Date Received | 2019-01-25 |
| Returned To Mfg | 2018-04-09 |
| Model Number | 41 SOMNOSTAR Z4 V9 |
| Catalog Number | 16846 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-01-25 |