Description of Event or Problem · 1
PRODUCT IS SUPPOSED TO BE DESIGNED TO POP-OFF AT PRESSURES BETWEEN 18-21 CMH2O. THE PRODUCT SHOULD THEN BE ABLE TO PREVENT BAROTRAUMA TO THE PATIENT AND THE PRESSURES AT THE POP-OFF SHOULD BE THE SAME AS WHAT IT IS AT THE NARES. INITIAL TESTING WAS CONDUCTED AND ALL PRESSURES WERE SUPPOSED TO BE EQUAL. UPON FURTHER EVALUATION IT WAS DETERMINED THAT AT FLOWS GREATER THAN 6LPM, THE PRODUCT IFU STATES IT CAN BE USED AT FLOWS FROM 5-10LPM; THE PRESSURE READING AT THE NARES WAS NOT CONSISTENT WITH THE MANUFACTURER CLAIMS. SECONDARY TESTING WAS CONDUCTED AND IT WAS FOUND THAT PRESSURES AT 6LPM AND HIGHER DID NOT HAVE THE SAME PRESSURE READING AT THE NARES AND POP-OFF. THE PRESSURES WERE SIGNIFICANTLY HIGHER AND COULD CAUSE TRAUMA TO THE PATIENT'S LUNGS.