Description of Event or Problem · 1
WHEN THE VENTILATOR CAME INTO THE SHOP FOR ROUTINE SERVICE, A BLACK DUST WAS NOTED IN THE NEBULIZER TUBING LEADING TO THE PATIENT CIRCUIT. THIS IS THE SECOND INSTANCE IN 3 YEARS WHERE THIS SYMPTON WAS NOTED IN AN AVEA VENTILATOR. THE BIOMEDICAL ENGINEER (BIOMED) SUSPECTS SOME TYPE OF DETERIORATION INSIDE THE NEBULIZER PUMP ASSEMBLY. THE BIOMED HAS CONCERNS THAT THERE IS NO RECOMMENDED FILTER ON THE NEBULIZER PORT TO CATCH/STOP THIS DUST FROM GOING INTO THE PATIENT CIRCUIT.====================== HEALTH PROFESSIONAL'S IMPRESSION======================DETERIORATION OF A SEAL INSIDE THE NEBULIZER ASSEMBLY IS CREATING A BLACK DUST THAT FINDS ITS WAY INTO THE PATIENT CIRCUIT AND ULTIMATELY INTO THE PATIENT.====================== MANUFACTURER RESPONSE FOR VENTILATOR, AVEA======================WE HAVE COMPLETED THE INVESTIGATION OF THE RETURNED NEBULIZER. OUR FINDINGS ARE AS FOLLOWS. FAILURE ANALYSIS: VERIFIED THE REPORTED ISSUE, THE ASSEMBLY WAS FULLY DISASSEMBLED AND FOUND "BLACK DUST" INTERNALLY. THIS DUST WAS FROM THE SEAL AROUND THE INNER PISTON ASSEMBLY. THE CAUSE OF THIS WAS MOST LIKELY DUE TO AN OUT OF SPECIFICATION INNER CYLINDER DIAMETER NEB HOUSING. THIS SPECIFICATION DISCREPANCY CAUSED THE PISTON AND SEAL TO GRIND AGAINST THE INNER CYLINDER RESULTING IN THE SEAL BECOMING PLIABLE AND RUBBING AGAINST THE INNER WALL. SINCE BOTH THE PISTON ASSEMBLY AND INNER SURFACE OF THE CYLINDER BLOCK ARE PHYSICALLY DAMAGED NO MEASUREMENTS COULD BE TAKEN. FINDINGS/ROOT-CAUSE: POSSIBLE BORING ISSUE OF THE NEBULIZER MANIFOLD BLOCK.NO RECOMMENDATIONS FOR PREVENTION OR SAFETY PRECAUTIONS FOR THE PATIENT (FILTER ON NEBULIZER PORT) WERE GIVEN.