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

Model Number	VMAX ENCORE 22D
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire file identification: (b)(4).At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
It is reported to vyaire medical that the vmax encore 22 experienced a burning smell upon installation of sample pump.The customer confirmed there was no patient involvement associated with the reported issue.
Additional Manufacturer Narrative
Result of investigation: vyaire medical was able to confirmed the reported issue through failure analysis and was able duplicate the issue.The reported failure of the vmax encore 22 unit assembly p/n 777494 s/n (b)(6) caused by a missing spacer washer.Therefor it causes a short circuit on a tracing of the analyzer control board.Also, the sample pump was replaced by the user.There was additional failures of the missing transparent cover for the power supply and the missing lock washers.These are due to insufficient reassembly after the sample pump was installed by the user.The missing nuts - nut hx dblsm 4-40thd stl* p/n 808594 on solenoid 2 - valve, solenoid, 5vdc, 3-way, 0-10psig p/n 464248 of the pressure board - pwb pressure board opt vmax m tsted p/n 775383 rev e s/n (b)(6) are the result of insufficient assembly during manufacturing.Submitted a supplemental report in accordance with 21 cfr section 803.56.

• Brand Name: VMAX ENCORE 22
• Common Device Name: CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda IL 92887
• MDR Report Key: 11599994
• Report Number: 2021710-2021-13640
• Device Sequence Number: 3520906
• Product Code: BTY
• UDI-Device Identifier: 10846446021417
• UDI-Public: (01)10846446021417(11)20190315
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2021

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: VMAX ENCORE 22D
• Device Catalogue Number: 777405-101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1