UNKNOWN

Additional Manufacturer Narrative

H6: 4756 (APPROPRIATE IMPACT TERM/CODE NOT AVAILABLE): MANUAL RESUSCITATION BAG. 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 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 27 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 (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, CAUSED, OR CONTRIBUTED TO A SERIOUS INJURY.

Description of Event or Problem

IT WAS REPORTED THAT A NEONATAL PATIENT IN THE ICU EXPERIENCED A DETERIORATION IN VITAL SIGNS, PROMPTING THE CARE TEAM TO INITIATE MANUAL VENTILATION. WHEN THE MANUAL RESUSCITATION BAG WAS SQUEEZED, THE PRESSURE MANOMETER DID NOT MOVE, AND THE CARE TEAM WAS UNSURE WHETHER EFFECTIVE BREATHS WERE BEING DELIVERED, AS CHEST RISE WAS DIFFICULT TO ASSESS. IT WAS LATER DETERMINED THAT THE ENDOTRACHEAL TUBE HAD BECOME DISPLACED PRIOR TO MANUAL VENTILATION. A NEW MANUAL RESUSCITATION BAG WAS OBTAINED AND PLACED INTO USE, AND THE PATIENT'S ENDOTRACHEAL TUBE WAS REMOVED AND REPLACED. FOLLOWING THESE INTERVENTIONS, THE PATIENT'S VITAL SIGNS NORMALIZED AND THE PATIENT'S CONDITION IMPROVED.

Description of Event or Problem

IT WAS REPORTED THAT A NEONATAL PATIENT IN THE ICU EXPERIENCED A DETERIORATION IN VITAL SIGNS, PROMPTING THE CARE TEAM TO INITIATE MANUAL VENTILATION. WHEN THE MANUAL RESUSCITATION BAG WAS SQUEEZED, THE PRESSURE MANOMETER DID NOT MOVE, AND THE CARE TEAM WAS UNSURE WHETHER EFFECTIVE BREATHS WERE BEING DELIVERED, AS CHEST RISE WAS DIFFICULT TO ASSESS. IT WAS LATER DETERMINED THAT THE ENDOTRACHEAL TUBE HAD BECOME DISPLACED PRIOR TO MANUAL VENTILATION. A NEW MANUAL RESUSCITATION BAG WAS OBTAINED AND PLACED INTO USE, AND THE PATIENT'S ENDOTRACHEAL TUBE WAS REMOVED AND REPLACED. FOLLOWING THESE INTERVENTIONS, THE PATIENT'S VITAL SIGNS NORMALIZED AND THE PATIENT'S CONDITION IMPROVED.

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 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 28 APR 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). 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