MEDLINE

Description of Event or Problem

IT WAS REPORTED THAT THE RESUSCITATION BAG WAS LEAKING AIR, WITH THE OXYGEN AREA INTERMITTENTLY POPPING OFF THE BACK, RESULTING IN INADEQUATE OXYGEN DELIVERY DURING RESUSCITATION. THE CUSTOMER ALSO REPORTED THAT AN UNSPECIFIED INJURY OCCURRED DURING THE EVENT; HOWEVER, NO ADDITIONAL DETAILS WERE PROVIDED.

Additional Manufacturer Narrative

H6: 4756 (APPROPRIATE IMPACT TERM/CODE NOT AVAILABLE): MANUAL RESUSCITATION BAG. 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 12 MAR 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 COMPLAINT (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 IS DEFECTIVE, CAUSED, OR CONTRIBUTED TO A SERIOUS INJURY.

Description of Event or Problem

IT WAS REPORTED THAT THE RESUSCITATION BAG WAS LEAKING AIR, WITH THE OXYGEN AREA INTERMITTENTLY POPPING OFF THE BACK, RESULTING IN INADEQUATE OXYGEN DELIVERY DURING RESUSCITATION. THE CUSTOMER ALSO REPORTED THAT AN UNSPECIFIED INJURY OCCURRED DURING THE EVENT; HOWEVER, NO ADDITIONAL DETAILS WERE PROVIDED.

Additional Manufacturer Narrative

H6: 4756 (APPROPRIATE IMPACT TERM/CODE NOT AVAILABLE): MANUAL RESUSCITATION BAG. CORRECTION: D9, H6. THE PRODUCT ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED FOR EVALUATION, AND NO PHOTOGRAPHIC OR VIDEOGRAPHIC EVIDENCE WAS PROVIDED. IN THE ABSENCE OF VISUAL DOCUMENTATION, THE COMPLAINT COULD NOT BE CONFIRMED; FURTHERMORE, WITHOUT A SAMPLE FOR FUNCTIONAL TESTING, THE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF COMPLAINT HISTORY IDENTIFIED ONE ADDITIONAL COMPLAINT INVOLVING THE SAME PART NUMBER AND A SIMILAR FAILURE MODE WITHIN THE PRECEDING 24 MONTHS. NO ADDITIONAL TRENDS WERE IDENTIFIED; MONITORING WILL CONTINUE FOR ANY EMERGING TRENDS. THE DEVICE HISTORY RECORD FOR LOT 582867 WAS REVIEWED, AND CONFIRMED THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 01 MAY 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 COMPLAINT- (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 IS DEFECTIVE, CAUSED, OR CONTRIBUTED TO A SERIOUS INJURY.