Medisorb

Additional Manufacturer Narrative

H6: 4MEDISORB - ABSORBER. THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 16 JULY 2026 HAS BEEN INCLUDED IN THE HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IS IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AIRLIFE PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY.

Description of Event or Problem

IT WAS DOCUMENTED THAT IT WAS REPORTED DURING A CLINICAL CASE ON (B)(6) 2026, AN ANESTHESIA MACHINE STOPPED VENTILATING AND HAD TO BE SWAPPED. A GAS LEAK WAS SUSPECTED, AND THE PATIENT WAS MANUALLY VENTILATED. THE PATIENT REPORTEDLY CODED BUT RECOVERED WITH NO DOCUMENTED LASTING CONSEQUENCE. FIELD SERVICE FOUND A MASSIVE LEAK IN THE ABS/BREATHING SYSTEM. IT WAS ADDITIONALLY REPORTED, THE CUSTOMER REPORTEDLY DID NOT COMPLETE A FULL TEST BEFORE USE ON (B)(6) 2026. LOG REVIEW FINDINGS: LOGS SHOWED MULTIPLE ALARMS INCLUDING ETCO, LOW, APNEA CO, APNEA VOL, BELLOWS COLLAPSED, DELIVERED VOLUME MISMATCH, LOW PAW, DRIVE GAS LOST, PRESS LOW, AND OTHERS. THE PATTERN WAS CONSIDERED MOST CONSISTENT WITH A LEAKING OR INTERMITTENTLY SEALING CO CANISTER, CAUSING GAS COMPOSITION AND PRESSURE INSTABILITY FINAL ASSESSMENT. CROSS-FUNCTIONAL REVIEW CONCLUDED THE ROOT CAUSE WAS A DAMAGED DISPOSABLE MEDISORB CANISTER, WHICH WAS NOT IMPORTED OR DISTRIBUTED BY GEHC. THE AISYS CS2 DID NOT CAUSE OR CONTRIBUTE TO THE ALLEGED SERIOUS INJURY; THE FAILURE WAS ATTRIBUTED TO A NON-GEHC DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED CONCERNING THE PATIENT'S OUTCOME.