The following description of the event was copied from a carefusion ventilation complaint form submitted on behalf of user facility in (b)(6) by the distributor in (b)(6)."after being set up and pressurized, the oscillator will dump the pressure immediately or hold the pressure for anything up to 20 minutes.Regardless if it is kept pressurized, or oscillating, it eventually dumps all the pressure at once.".
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Failure analysis: 3100a alarm board assy pn: 768588, sn: (b)(4) was received and routed to the carefusion failure analysis lab for evaluation.The carefusion failure analysis lab technician evaluated the alarm board assy and found that along with a corresponding audible alarm, the hi paw led and min paw led were coming on intermittently.It was found that the output voltage at comparator ic u5 pin 1 and pin 14 were going low with no alarm condition causes the ventilator to dump its patient circuit pressure and shut down.The failure analysis lab technician replaced u5 and now the ventilator is functioning normally.Finding/root-cause: duplicated, unit dumps the patient circuit pressure, complaint allegation.Defective ic u5, ic-339 v comparator low power pn: 861648.
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