VENTLAB

Additional Manufacturer Narrative

CORRECTION: B5. 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 21 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 (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.

Description of Event or Problem

IT WAS REPORTED THAT THERE WERE DIFFICULTIES CONNECTING THE RESUSCITATION MASK TO THE BAG BECAUSE THE INCLUDED MASK WAS NOT SUFFICIENTLY INFLATED WHEN REMOVED FROM THE PACKAGING. INFLATION WITH A SYRINGE WAS REQUIRED. THERE WERE NO DELAYS IN THERAPY, HARM, OR INJURY REPORTED AS A RESULT OF THIS ISSUE. AIRLIFE RECEIVED A SINGLE REPORT THAT REFERENCED MULTIPLE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS AND INVOLVED DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 1314417-2025-00100 FOR THE SECOND REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THERE WERE DIFFICULTIES CONNECTING THE RESUSCITATION MASK TO THE BAG BECAUSE THE INCLUDED MASK WAS NOT SUFFICIENTLY INFLATED WHEN REMOVED FROM THE PACKAGING. INFLATION WITH A SYRINGE WAS REQUIRED. THERE WERE NO DELAYS IN THERAPY, HARM, OR INJURY REPORTED AS A RESULT OF THIS ISSUE. SUNMED HOLDINGS LLC RECEIVED A SINGLE REPORT THAT REFERENCED MULTIPLE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS AND INVOLVED DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 1314417-2025-00100 FOR THE SECOND REPORT.

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 20 NOV 2025 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 SUN MED HOLDINGS LLC. 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 SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. 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 SUN MED HOLDINGS 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 A SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.