AIRLIFE
Report
- Report Number
- 3010838917-2025-00011
- Event Type
- Malfunction
- Date Received
- December 5, 2025
- Date of Event
- November 4, 2025
- Report Date
- January 29, 2026
- Manufacturer
- AIRLIFE FINLAND OY
- Product Code
- CAH
- UDI-DI
- 70190752139758
- PMA / PMN Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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 05 DEC 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 21CFR803, 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.
THE COMPLAINT PRODUCT WAS RETURNED TO THE SUPPLIER FOR EVALUATION. FUNCTIONAL TESTING WAS CONDUCTED ON THE RETURNED UNIT, AND THE REPORTED CONDITION WAS CONFIRMED. THE DEVICE EXHIBITED LEAKAGE ORIGINATING FROM THE WELDED SEAM. THE INVESTIGATION DETERMINED THAT THE ROOT CAUSE WAS A MANUFACTURING ERROR, SPECIFICALLY MISALIGNMENT OF THE FILTER DURING ASSEMBLY, WHICH RESULTED IN A WEAKENED WELDED SEAM. 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 0209655 WAS REVIEWED, AND CONFIRMED THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 29 JAN 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 HOLDINGS 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 WAS DEFECTIVE OR CAUSED SERIOUS INJURY.
IT WAS REPORTED THAT AIR WAS LEAKING, ALTHOUGH NO GAPS WERE OBSERVED BETWEEN THE TOP AND BOTTOM OF THE COMPONENT.
IT WAS REPORTED THAT AIR WAS LEAKING, ALTHOUGH NO GAPS WERE OBSERVED BETWEEN THE TOP AND BOTTOM OF THE COMPONENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2810204 | AIRLIFE | UNI-FILTER, DISPOSABLE | CAH | AIRLIFE FINLAND OY | 557021200 | 0209655 | 70190752139758 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |