MAUDE Adverse Event Report: AIRLIFE FINLAND OY AIRLIFE; UNI-FILTER, DISPOSABLE

Model Number	557021200
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that air was leaking, although no gaps were observed between the top and bottom of the component.
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that air was leaking, although no gaps were observed between the top and bottom of the component.

• Brand Name: AIRLIFE
• Common Device Name: UNI-FILTER, DISPOSABLE
• Manufacturer (Section D): AIRLIFE FINLAND OY; kuortaneenkatu 2; helsinki, uusimaa FIN-0 0510; FI FIN-00510
• Manufacturer (Section G): AIRLIFE FINLAND OY; kuortaneenkatu 2; helsinki, uusimaa FIN-0 0510; FI FIN-00510
• Manufacturer Contact: candacy bush ; 2710 northridge dr. nw, suite a; grand rapids, MI 49544
• MDR Report Key: 23728322
• Report Number: 3010838917-2025-00011
• Device Sequence Number: 10192623
• Product Code: CAH
• UDI-Device Identifier: 70190752139758
• UDI-Public: (01)70190752139758(10)0209655(17)280313
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 557021200
• Device Lot Number: 0209655
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown