MAUDE Adverse Event Report: VYAIRE MEDICAL VMAX ENCORE 22; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	777404-101
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/19/2019
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.A vyaire medical failure analysis technician was able to duplicate the reported issue.The root cause was determined to be demand valve, which was further determined to be a known issue and no further investigation would be warranted.
Event or Problem Description
It was reported to vyaire medical that the vmax encore 22 was experiencing high lung volumes while connected to a patient.At this time, it is unknown if there was any patient harm or intervention taken.

• Brand Name: VMAX ENCORE 22
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 11016388
• Report Number: 2021710-2020-13043
• Device Sequence Number: 3823530
• Product Code: BTY
• UDI-Device Identifier: 10846446021394
• UDI-Public: (01)10846446021394(11)20050601
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2019

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: 777404-101
• Device Catalogue Number: 777404-101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1