MINIHEART

Additional Manufacturer Narrative

H6: 4756 (APPROPRIATE TERM/CODE NOT AVAILABLE): NEBULIZER. THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 01 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 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 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 AN AIRLIFE PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

Description of Event or Problem

IT WAS REPORTED THAT THE TUBING DISCONNECTED FROM THE FLOW METER MULTIPLE TIMES DURING CONTINUOUS USE WHEN SET TO THE RECOMMENDED FLOW RATE OF 8 L/MIN. THERE WAS NO REPORTED DELAY IN THERAPY, HARM, OR INJURY ASSOCIATED WITH THIS EVENT.