Description of Event or Problem · 1
DR IN THE PATIENT ROOM NOTIFIED RESPIRATORY THERAPIST (RT) THAT THE VENTILATOR WAS NOT WORKING PROPERLY, THAT THE PISTON WAS NOT CENTERED AND THE VENTILATOR SOUNDED WRONG. RT WENT INTO THE ROOM AND THE PISTON RED LIGHTS WERE OFF TO THE FAR LEFT AND THE PISTON ADJUSTMENT KNOB WOULD NOT MOVE TO THE RIGHT ANY FURTHER. THE RN AND DR BOTH COMMENTED THAT THE AMPLITUDE READING DROPPED FROM THE 70S TO THE 30S AND AT THAT TIME THE VENTILATOR STARTED SOUNDING WIERD TO THEM. THE NURSE ALSO STATED SHE THOUGHT SHE SMELLED A "HOT" SMELL. RT COULD NOT SMELL IT BUT DECIDED AT THAT TIME TO EXCHANGE OUT THE UNIT FOR A DIFFERENT ONE. AT THAT TIME THE DR DECIDED TO TAKE THE PATIENT OFF THE VENT AND BEGAN BAGGING WHILE THE UNIT WAS EXCHANGED. PATIENT IS IN PICU WITH RESPIRATORY FAILURE AND SHOCK. PRIOR TO USING THE HIGH FREQUENCY OSCILLATING VENTILATOR, PATIENT HAD BEEN ON A CONVENTIONAL VENTILATOR, BUT WAS IN RESPIRATORY DISTRESS AND HAD POOR PERFUSION. PATIENT WAS PUT ON HFOV AND LAB VALUES AT THAT TIME WERE TCPCO2= 63, DELTA P =74 AND SETTINGS WERE MAP =28, HERTZ=10 AND POWER =7.5. AT TIME OF THE VENTILATOR MALFUNCTION, PATIENT'S TCPCO2= 71 AND DELTA P =41; PATIENT WAS BAGGED AND RECEIVING 100% O2. PATIENT RESPONDED WELL AND APPROXIMATELY 45 MINUTES LATER WHEN PATIENT WAS ON ANOTHER HFOV, VALUES WERE TCPCO2=71, DELTA P=71 AND SETTINGS MAP=36, HERTZ=10, AND POWER 8.5-9. PATIENT CONDITION AFTER THE VENTILATOR MALFUNCTION WAS UNCHANGED FROM CONDITION BEFORE THE MALFUNCTION- THUS NO PATIENT HARM RESULTED FROM THIS EVENT. PATIENT REMAINS IN PICU IN CRITICAL CONDITION RELATED TO HER MEDICAL DIAGNOSES. THIS SAME HFOV WAS REPORTED TO FDA IN 2011 BECAUSE OF A PISTON THAT WAS NOT CENTERED. THE HFOV WAS RETURNED TO THE MANUFACTURER IN 2011 AND WAS REBUILT. HFOV HAS HAD REQUIRED PREVENTIVE MAINTENANCE AND 1 EPISODE IN 2013 REQUIRING THE MANUFACTURER TO ADJUST THE DRIVER CONTROLLER. THE HFOV IS SEQUESTERED AT THE HOSPITAL. THE MANUFACTURER WILL INVESTIGATE THIS EVENT AFTER SIGNING RELEASE OF NONDESTRUCTIVE TESTING MEMO OF UNDERSTANDING.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?TREATMENT OF ACUTE RESPIRATORY FAILURE WITH HIGH FREQUENCY OSCILLATING VENTILATOR.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.