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.
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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.
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