MAUDE Adverse Event Report: VYAIRE MEDICAL SOMNOSTAR Z4 SYSTEM VER 11; STANDARD POLYSOMNOGRAPH WITH ELECTROENCEPHALOGRAPH

Model Number	SOMNOSTAR
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Results of investigation: vyaire received a sample of test results of the study provided by the customer.The issue was duplicated using the study supplied by the patient and running the default split night report.It is confirmed that the software has provided an incorrect data with hr values.This issue will be internally investigated within vyaire.
Event or Problem Description
The customer reported the issue with the software indicating that the heart rate (hr) reading is unusually below average or describes as incorrect values.The customer reported that the medical director of the facility noticed that the hr of 27 beats per minute (bpm) and was considering to refer to a cardiologist based on the test results.
Additional Manufacturer Narrative
G4, g7,h2, h6, h10: the vyaire medical service technician was able to verify the reported issue as this is determined to be a known issue.Result of investigation: the customer was sent a rga to send the study and report templates for review.It was determined to be a known issue in the software.The resolution will be to incorporate a fix for this issue into the next somnostar software release - version 11.4.

• Brand Name: SOMNOSTAR Z4 SYSTEM VER 11
• Common Device Name: STANDARD POLYSOMNOGRAPH WITH ELECTROENCEPHALOGRAPH
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 8745727
• Report Number: 2021710-2019-10445
• Device Sequence Number: 14086993
• Product Code: OLV
• UDI-Device Identifier: 10846446032604
• UDI-Public: (01)10846446032604(11)20050901
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K012085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SOMNOSTAR
• Device Catalogue Number: 28483-001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/12/2019
• Supplement Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 06/28/2019
• Supplement Report FDA Received Date: 11/19/2020
• 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: Other