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

Model Number VMAX 22D E

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 12/23/2020

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.

Event 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
• Type of Device: CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
• 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: 10686886
• MDR Text Key: 211684718
• Report Number: 2021710-2020-12725
• Device Sequence Number: 1
• Product Code: BTY
• UDI-Device Identifier: 10846446021417
• UDI-Public: (01)10846446021417(11)20091016
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: VMAX 22D E
• Device Catalogue Number: 777405-101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2020
• Initial Date FDA Received: 10/15/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/16/2009
• 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