VENTLAB

Description of Event or Problem

IT WAS REPORTED THAT, ON (B)(6) 2026, DURING AN INTUBATION AND RESUSCITATION EVENT INVOLVING A PEDIATRIC PATIENT, THE PEDIATRIC BAG VALVE MASK (P BVM) WITH PRESSURE MANOMETER REACHED THE POP-OFF LIMIT OF 40 AND REMAINED AT THIS LEVEL DURING BAGGING, WITHOUT DECREASING DURING EXHALATION. WHEN THE PATIENT WAS DISCONNECTED FROM THE ENDOTRACHEAL TUBE (ETT), THE MANOMETER RETURNED TO ZERO; HOWEVER, UPON RECONNECTION AND CONTINUED USE, IT REMAINED AT 40. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. THE DOCUMENTED UDI IS BASED ON THE STOCK/PRODUCT CODE PROVIDED BY THE REPORTER; THE UDI-PI IS NOT AVAILABLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 26 JUNE 2026 HAS BEEN INCLUDED IN THIS 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 INFORMATION KNOWN 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 PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IDENTIFIED AS (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21 CFR 803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT, AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AIRLIFE PRODUCT WAS DEFECTIVE OR CAUSED SERIOUS INJURY.