MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE

Additional Manufacturer Narrative

AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. NO ROOT CAUSE HAS BEEN DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 8003138-MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE DID NOT PASS THE CHECKS FOR AUTOMATIC VENTILATION NOR FOR MANUAL VENTILATION. THE SODA LIME CANISTER WAS REMOVED FOR INSPECTION, AND IT WAS FOUND THAT THERE WAS NO DAMAGE TO THE CANISTER. THE SODA LIME CANISTER WAS REPOSITIONED AND THE USER TEST WAS PASSED AGAIN. THE MEDISORB HAS NOW SUCCESSFULLY PASSED THE AUTOMATIC AND MANUAL USER TESTS. ONCE PUT INTO NORMAL OPERATION FOR A FIXED VT OF 500 ML (VCV MODE), THE EQUIPMENT SHOWS A VT OF 488 ML. INTENSIVE TESTS WERE CARRIED OUT TO ENSURE THE PROPER FUNCTIONING OF THE EQUIPMENT. DURING THE INCIDENT, THE USER BEGAN TO VENTILATE IN MANUAL MODE AND THEN DE-INTUBATED THE PATIENT. THE ENDOSCOPIC PROCEDURE WAS DISCONTINUED BUT THERE WAS NO PATIENT HARM.