Description of Event or Problem · 1
DURING PREVENTIVE MAINTENANCE (PM) INSPECTION, FOUND CRACKS ON PSOL (PROPORTIONAL SOLENOID)SOLENOID VALVE ON 2 OF THE VENTILATORS INSPECTED. THIS WAS NOTED DURING AN ANNUAL PM WHERE A FILTER WITHIN THIS ASSEMBLY NEEDS TO BE REPLACED AS PART OF THE PM KIT. IT DID NOT FAIL ANY OF THE INSPECTION TESTING, SO THERE WAS NO INDICATION FROM THE VENTILATOR THAT THE FAILURE HAD OCCURRED FROM ANY VISUAL OR AUDIBLE ALARM. THE FAILURE NOTED IN ALL INSTANCES SO FAR HAS ONLY CRACKED ON ONE-HALF OF THE COLLAR AND NOT COMPLETELY THROUGH AND THROUGH.IF IT HAD CRACKED THROUGH AND THROUGH, AN ERROR WOULD HAVE OCCURRED THAT WOULD HAVE SHUT DOWN THE VENTILATOR. NO GASES FLOW THROUGH THIS COLLAR, BUT IT DOES LOCK IN THE CALIBRATED SETTING OF THIS SOLENOID WHICH IS USED BY THE FLOW SENSOR THAT IS NEARBY IN THE ASSEMBLY. THERE HAVE BEEN SIX OF THE THIRTEEN (46%) WE HAVE REVIEWED, OUT OF A TOTAL OF TWENTY FIVE VENTILATORS OWNED. CLINICAL ENGINEERING'S RECOMMENDATION WILL BE TO CONTINUE TO EVALUATE THE REMAINING UNITS (TWELVE UNITS), BUT REQUEST THAT ALL OF THESE SOLENOIDS BE REPLACED ON OUR ENTIRE INVENTORY DURING THE TIME THAT COVIDIEN WILL BE EVALUATING TO DETERMINE THE ROOT CAUSE OF THE FAILURE.IN ORDER TO ASSESS THE RISK AND PREVENT POSSIBLE FUTURE FAILURE WE ARE WORKING WITH COVIDIEN AND RESPIRATORY DEPARTMENT; HAVE CHECKED A TOTAL OF 8 VENTILATORS OUT OF 25 AND FOUND 3 WITH CRACKED SOLENOIDS. THE PLAN IS TO CHECK THE REST OF THE VENTILATORS AND REPLACE ALL OF THE SOLENOID VALVES ON THE VENTILATORS AND HAVE THE CRACKED VALVES INVESTIGATED BY COVIDIEN TO AVOID IT FROM HAPPENING IN THE FUTURE.