MAUDE Adverse Event Report: VYAIRE MEDICAL INC STANDARD POLYSOMNOGRAPHY WITH ELECTROENCEPHALOGRAPH; SOMNOSTAR & SERIES SLEEP SYTEM

Model Number 41 SOMNOSTAR Z4 V9

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2018

Event Type  malfunction  

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 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 with the event.

• Brand Name: STANDARD POLYSOMNOGRAPHY WITH ELECTROENCEPHALOGRAPH
• Type of Device: SOMNOSTAR & SERIES SLEEP SYTEM
• Manufacturer (Section D): VYAIRE MEDICAL INC; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): DUCOMMUN LA BARGE; 2222 east pensar drive; appleton WI 54911 8789
• Manufacturer Contact: stanley tan ; 22745 savi ranch parkway; yorba linda, CA 92887 ; 7607787281
• MDR Report Key: 8279651
• MDR Text Key: 134308173
• Report Number: 2021710-2019-08034
• Device Sequence Number: 1
• Product Code: GWQ
• UDI-Device Identifier: 10846446020076
• UDI-Public: (01)10846446020076
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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: 04/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/12/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other