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

Model Number	22 E
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire file identification: (b)(4).Any additional information received from the customer will be included in a follow-up report.The customer reported the suspected component is available for analysis and was ordered for return.At this time, vyaire has not received the suspected component for evaluation.
Event or Problem Description
The customer reported during installation of a device, the vmax encore 22 e was not functioning.When the customer changed the oxygen (o2) cell, reconnected the vacuum pump, the board started to burn.When the customer installed the same o2 cell on a loaner unit afterwards, the o2 cell was not functional.The customer reported it is unclear if the device burning of the board had anything to do with the o2 cell device not being functional when used.The customer reported there is no patient involvement associated with the event.
Additional Manufacturer Narrative
Results of investigation: the vyaire failure analysis lab received the suspected device/component and performed a failure investigation.The reported problem was not duplicated, therefore, the root cause was not determined.

• Brand Name: VMAX ENCORE 22
• Common Device Name: CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 9593820
• Report Number: 2021710-2020-11283
• Device Sequence Number: 595638
• Product Code: BTY
• UDI-Device Identifier: 10846446021394
• UDI-Public: (01)10846446021394(11)20170102
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K942211
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2019

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: 22 E
• Device Catalogue Number: 777404-101
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 06/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1