MAUDE Adverse Event Report: VYAIRE MEDICAL INC. STANDARD POLYSOMNOGRAPHY WITH ELECTROENCEPHALOGRAM; SOMNOSTAR & SERIES SLEEP SYSTEM

Model Number	41 SOMNOSTAR Z4 V9
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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 in this event.The suspect amplifier has been returned to vyaire for investigation.

• Brand Name: STANDARD POLYSOMNOGRAPHY WITH ELECTROENCEPHALOGRAM
• Common Device Name: SOMNOSTAR & SERIES SLEEP SYSTEM
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 22745 savi ranch parkway; yorba linda CA 92887
• MDR Report Key: 8279908
• Report Number: 2021710-2019-08035
• Device Sequence Number: 11334083
• Product Code: GWQ
• UDI-Device Identifier: 10846446020076
• UDI-Public: (01)10846446020076
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K012085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 41 SOMNOSTAR Z4 V9
• Device Catalogue Number: 16846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Initial Date Received by Manufacturer: 05/07/2018
• Supplement Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 01/25/2019
• Supplement Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Other