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

Model Number 22 E

Device Problem Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 12/05/2019

Event Type  malfunction  

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 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.

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
• Type of Device: CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 9593820
• MDR Text Key: 175172110
• Report Number: 2021710-2020-11283
• Device Sequence Number: 1
• Product Code: BTY
• UDI-Device Identifier: 10846446021394
• UDI-Public: (01)10846446021394(11)20170102
• Combination Product (y/n): N
• PMA/PMN Number: K942211
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22 E
• Device Catalogue Number: 777404-101
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1