Description of Event or Problem · 0
THE COMPLAINT INVOLVED A VOLUME TEST FAILURE ON A TRILOGY EVO VENTILATOR. THE FAILURE WAS REPRODUCIBLE DURING TESTING. AT THE TIME OF THE EVENT, NO PATIENT WAS CONNECTED TO THE DEVICE, AND NO ALARMS WERE TRIGGERED. THE DEVICE WAS SET TO STANDARD CLINICAL VENTILATION MODES. THE REPORTED OUTCOME WAS A DEVICE FAILURE TO MEET VOLUME DELIVERY SPECIFICATIONS, WITH NO PATIENT HARM REPORTED. UPON EVALUATION, DIAGNOSTIC ERROR CODES INDICATED INTERNAL BATTERY DEPLETION AND PERMANENT FAILURE (ERRORS 44, 47, 237) AS WELL AS SYSTEM PCA FAULTS RELATED TO SENSOR MONITORING (ERRORS 211, 330). THESE FAILURES DIRECTLY CONTRIBUTED TO THE VOLUME TEST FAILURE. THE INTERNAL BATTERY AND SYSTEM PCA WERE REPLACED AS PART OF THE CORRECTIVE ACTION. FOLLOWING REPAIR, THE DEVICE PASSED ALL FUNCTIONAL TESTS. ADDITIONAL SERVICES INCLUDED REPLACEMENT OF CONTAMINATED BLOWER COMPONENTS, BLOWER MOUNTS, AND IN-LINE FILTERS DUE TO CORROSION AND CONTAMINATION. THE AIR INLET FOAM FILTER WAS ALSO REPLACED AS PART OF PREVENTIVE MAINTENANCE. THESE FINDINGS WERE UNRELATED TO THE VOLUME TEST FAILURE AND ARE CONSIDERED NON-REPORTABLE. THE FINAL FUNCTIONAL TEST PASSED, AND THE EVALUATION IS COMPLETE.