Additional Manufacturer Narrative · 1
THE VENTILATOR WAS INVESTIGATED ON SITE BY OUR FIELD SVC ENGINEER (FSE). THE REPORTED PROBLEM WAS NOT REPRODUCED AND NO FAULT WAS FOUND. NO PARTS WERE EXCHANGED. THE LOGS WERE DOWNLOADED AND THE VENTILATOR WAS RETURNED TO SVC. EVAL OF THE LOGS SHOWS "PAW HIGH" ALARMS IN RELATION TO THE ALARM: "REGULATION PRESSURE LIMITED". "REGULATION PRESSURE LIMITED" IS GENERATED IN THE PRVC (PRESSURE REGULATED VOLUME CONTROL) OR VS (VOLUME SUPPORT) MODE WHEN IT IS NOT POSSIBLE TO REACH THE SET VOLUME DUE TO RESTRICTIONS IMPOSED BY THE SET "UPPER PRESSURE LIMIT". HERE THE VENTILATION MODE WAS PRVC (THE VENTILATOR DELIVERS A PRE-SET TIDAL VOLUME AND THE PRESSURE IS AUTOMATICALLY REGULATED TO THE PRE-SET VOLUME BUT LIMITED TO 5 CMH2O BELOW THE SET UPPER PRESSURE LIMIT). "PAW HIGH" IS GENERATED WHEN THE AIRWAY PRESSURE EXCEEDS PRESENT "UPPER PRESSURE LIMIT". IF THE AIRWAY PRESSURE LIES NEAR THE "UPPER PRESSURE LIMIT" IT IS ENOUGH WITH THE PT COUGHING OR FIGHTING THE VENTILATOR TO RECEIVE A "PAW HIGH" ALARM. WHEN THE DELIVERED VOLUME LIES BELOW 50% OF SET VOLUME IN PRVC A NEW START BREATH IS MADE TO FIND THE SUITABLE PRESSURE LEVEL AND WITH CURRENT CONDITIONS THAT BREATH WILL MOST LIKELY CAUSE A "PAW HIGH" ALARM. THE LOGS SHOWED THAT TO DELIVER THE SET VOLUME THE VENTILATOR NEEDED A HIGHER PRESSURE THAN THE SET UPPER PRESSURE LIMIT. ACCORDING TO THE HOSP THE ALARMS WERE GENERATED AFTER FIVE DAYS WHICH INDICATES THAT THE INSPIRATORY RESISTANCE HAD INCREASED, WHY HAS NOT BEEN DETERMINED BUT THE FINDINGS OF THE FSE INDICATES THAT THERE WAS NO VENTILATOR MALFUNCTION.