(b)(4).The third party servicing company evaluated the ventilator and was able to start the driver when he depressed the start/stop button.However, after running about 20 seconds, the entire vent would just power down.The audible alarm would sound, but he could not silence the alarm.Evaluation by the carefusion failure analysis technician is anticipated but has not yet begun.(b)(4).
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The carefusion failure analysis engineer examined the 3100a ventilator and found that the driver does not operate.Traced problem to driver power module assy.Found that 3100 wavgen ic, u3 on driver controller pcba has no output at pin 3.Replaced 3100 wavgen ic, u3, and now the ventilator functions normally.Finding/root-cause: duplicated, driver doesn't start, complaint allegation.3100 wavgen ic, u3 on driver controller pcba no output at pin 3.
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