MEDLINE INDUSTRIES, INC.

Additional Manufacturer Narrative

H6: 4756 (APPROPRIATE IMPACT TERM/CODE NOT AVAILABLE): RESUS. 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 27 FEB 2025 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 A AIRLIFE PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY. THE COMPLAINT OF "FRACTION OF INSPIRED CO2 WAS RISING WHICH TO ME SUGGESTED REBREATHING AND POTENTIAL BVM OR OXYGEN FLOW MALFUNCTION" REGARDING PART CPRM1126FP WAS NOT CONFIRMED. THE ROOT CAUSE WAS NOT DETERMINED BUT COULD POSSIBLY BE A RESULT OF THE NON-REBREATHING PATIENT VALVE MALFUNCTIONS. A RISK ASSESSMENT WAS PERFORMED AND THE ULTIMATE RISK WAS DETERMINED TO BE MEDIUM WHICH DOES NOT REQUIRE ESCALATION TO THE CAPA REVIEW BOARD. THERE HAVE BEEN 0 OTHER COMPLAINTS REGARDING THE SAME PARTS AND A SIMILAR ISSUE WITHIN THE 24 MONTHS PRECEDING THIS REPORTED EVENT. A RESOLUTION LETTER WAS SENT TO THE CUSTOMER. COMPLAINTS WILL CONTINUE TO BE MONITORED FOR POSSIBLE TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WAS IMMEDIATELY STATUS POST INTUBATION, NOTED TYPICAL END-TIDAL CO2 WAVEFORM HOWEVER FRACTION OF INSPIRED CO2 ON CAPNOGRAPHY CONTINUED TO RISE AS DID END-TIDAL CO2, PATIENT DID NOT BECOME HYPOXIC OR UNSTABLE AND RECALIBRATED CAPNOGRAPHY ON THE MONITOR AS WELL AS CHECKED WITH ANOTHER CAPNOGRAPHY ON ZOLL. THIS ALSO CONFIRMED THAT FRACTION OF INSPIRED CO2 WAS RISING WHICH TO ME SUGGESTED REBREATHING AND POTENTIAL BVM OR OXYGEN FLOW MALFUNCTION. OXYGEN WAS CONFIRMED TO BE FLOWING. AT THIS TIME END-TIDAL HAD RISEN INTO THE 60S, WITH FRACTION OF INSPIRED CO2 IN THE LOW 20S.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WAS IMMEDIATELY STATUS POST INTUBATION, NOTED TYPICAL END-TIDAL CO2 WAVEFORM HOWEVER FRACTION OF INSPIRED CO2 ON CAPNOGRAPHY CONTINUED TO RISE AS DID END-TIDAL CO2, PATIENT DID NOT BECOME HYPOXIC OR UNSTABLE AND RECALIBRATED CAPNOGRAPHY ON THE MONITOR AS WELL AS CHECKED WITH ANOTHER CAPNOGRAPHY ON ZOLL. THIS ALSO CONFIRMED THAT FRACTION OF INSPIRED CO2 WAS RISING WHICH TO ME SUGGESTED REBREATHING AND POTENTIAL BVM OR OXYGEN FLOW MALFUNCTION. OXYGEN WAS CONFIRMED TO BE FLOWING. AT THIS TIME END-TIDAL HAD RISEN INTO THE 60S, WITH FRACTION OF INSPIRED CO2 IN THE LOW 20S.

Additional Manufacturer Narrative

H6: 4756 (APPROPRIATE IMPACT TERM/CODE NOT AVAILABLE): RESUS 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 27 FEB 2025 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 (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 A AIRLIFE PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY.