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 2018-06-26 for STANDARD POLYSOMNOGRAPH WITH ELECTROENCEPHALOGRAPH 41 SOMNOSTAR Z4 V10 16846 manufactured by Vyaire Medical.
[112422574]
(b)(4). At this time, vyaire has not received the suspect device/component for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[112422575]
The customer reported the power supply to the camera is very hot to touch and shows a brown like burnt discoloration on its surface. The power supply has been removed from use and there is no patient involvement associated with the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2018-09017 |
| MDR Report Key | 7638610 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-06-26 |
| Date of Report | 2018-06-25 |
| Date of Event | 2018-06-19 |
| Date Mfgr Received | 2018-06-19 |
| Device Manufacturer Date | 2016-06-30 |
| Date Added to Maude | 2018-06-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | MINDY FABER |
| Manufacturer Street | 26125 NORTH RIVERWOODS BLVD |
| Manufacturer City | METTAWA IL 60045 |
| Manufacturer Country | US |
| Manufacturer Postal | 60045 |
| Manufacturer Phone | 8727570116 |
| Manufacturer G1 | VYAIRE MEDICAL INC. |
| Manufacturer City | PALM SPRINGS 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 | SOMNOSTAR & SERIES SLEEP SYSTEM |
| Product Code | OLV |
| Date Received | 2018-06-26 |
| Model Number | 41 SOMNOSTAR Z4 V10 |
| Catalog Number | 16846 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL |
| Manufacturer Address | 26125 NORTH RIVERWOODS BLVD METTAWA IL 60045 US 60045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-26 |