MAUDE Adverse Event Report: VYAIRE MEDICAL VMAX ENCORE 22D; CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION

Model Number	VMAX 22D E
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire complaint number (b)(4).Any additional information provided by the customer will be included in a follow-up report.
Event or Problem Description
A customer contacted vyaire medical to report that they noted the fan inside the dell pc was, "whining and smelled hot." upon replacing the pc, they started getting gas not connected warnings even though they were connected to the wall o2.Customer was advised to put the pc back to the original system, and replace the sol cable from the system in order to resolve the communication problem.There was no patient involvement.

• Brand Name: VMAX ENCORE 22D
• Common Device Name: CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 10686886
• Report Number: 2021710-2020-12725
• Device Sequence Number: 19635312
• Product Code: BTY
• UDI-Device Identifier: 10846446021417
• UDI-Public: (01)10846446021417(11)20091016
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K942211
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VMAX 22D E
• Device Catalogue Number: 777405-101
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 10/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1