The following descriptions of the event were documented by a carefusion technical support specialist in response to a phone conversation with a user facility representative."problems with volumes, both in dlco and fvl.Changed out mfs seemed to come in okay after mfs cleaning on cal screen.She will monitor testing today and call back if needed and definitely call back in the morning once morning work up completed." :spoke with customer again, volumes shifting at times seems to be totally inconsistent in volume measurement intermittent will dispatch for on site, customer will have po." the following description of the event was copied from the user facility medwatch report received by carefusion from the fda on 12/23/2014."title: xxxxx.Event description: there was a drift in average correction factors on the pulmonary function testing (pft) machine; result in the possibilities of unreliable results.It was discovered that there was a leak in a tube." "manufacturer response for the pft machine and bodybox, carefusion vmax pft machine (per site reporter)." "carefusion tech serviceman came and discovered the leak in a tube and corrected the problem and serviced it.Also evaluated the pft machine for any further issues - there was none.Service tech suggested ways to recheck for leaks." "what was the original intended procedure: pft testing." "device usage problem: device malfunction - that is, the device did not do what it was supposed to do.".
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