Description of Event or Problem · 1
THIS FAILURE WAS DISCOVERED DURING PRE-PATIENT CHECK OUT.MANUFACTURER: SENSORMEDICS, MODEL 3100B HIGH FREQUENCY OSCILLATORY VENTILATOR. THE VENTILATOR LISTED ABOVE IS GETTING WATER INTO THE AIRWAY PRESSURE TUBING, WHICH THEN MAKES ITS WAY TO THE PRESSURE TRANSDUCER. WHEN TESTING THE 3100B, THE INITIAL SETTINGS WERE ALL CORRECT, BUT AFTER A COUPLE OF HOURS OF RUNNING, THE DELTA PRESSURE (P) STARTED DROPPING. INCREASING THE MEAN PRESSURE (MAP) AND/OR BIAS FLOW DID NOT STOP THE DELTA P FROM FALLING. A BUBBLE OF WATER WAS DISCOVERED SITTING ON TOP OF THE PRESSURE TRANSDUCER CAUSING THE DELTA P TO FALL. REMOVING THE AIRWAY PRESSURE TUBE AND USING COMPRESSED AIR TO BLOW OUT THE WATER, SETTINGS RETURNED TO NORMAL. THE PNEUMATIC BLOCK DIAGRAM SHOWS THERE IS NO FILTERS TO CATCH MOISTURE FOR THIS AIRWAY PRESSURE LINE. USING AN ADULT CIRCUIT AND A FISHER PAYKEL MR850 HEATER, THE EXPIRATORY LIMB OF THE CIRCUIT HAS EXCESSIVE RAIN OUT. SERVICE TECHNICIAN IDENTIFIED MOISTURE BUILD-UP ON THE PR-6 "AIRWAY PRESSURE MONITOR" PRESSURE TRANSDUCER. THE DEVICE HAS SINCE BEEN TAKEN OUT OF SERVICE UNTIL THE UNDERLYING CAUSE OF THE MOISTURE BUILD-UP HAS BEEN DETERMINED. THE DEVICE PROBLEM OF MOISTURE BUILD-UP IS REPRODUCIBLE AND OCCURS WITHIN 10 MINUTES OF INITIAL TEST VENTILATION.======================MANUFACTURER RESPONSE FOR HIGH FREQUENCY VENTILATOR, SENSORMEDICS 3100 HIGH FREQUENCY VENTILATOR (PER SITE REPORTER)======================"THEY ARE AWARE OF THE PROBLEM AND ARE WATCHING IT".