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

Model Number 777404-101

Device Problem Output Problem (3005)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/19/2019

Event Type  malfunction  

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 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
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: peter sparacio ; 26125 n. riverwoods blvd.; mettawa, IL 60045 ; 8333273284
• MDR Report Key: 11016388
• MDR Text Key: 221773317
• Report Number: 2021710-2020-13043
• Device Sequence Number: 1
• Product Code: BTY
• UDI-Device Identifier: 10846446021394
• UDI-Public: (01)10846446021394(11)20050601
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K942211
• 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: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2019
• Initial Date FDA Received: 12/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2005
• 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