MAUDE Adverse Event Report: AIRLIFE FINLAND OY N/A; T-PIECE NEONATAL PATIENT CIRCUIT KIT, DISPOSABLE

Model Number	M1091365VS
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Annex g - 4756 - appropriate component term/code not available - t-piece neonatal patient circuit kit.The product involved in the report has not been returned for evaluation.The customer reported that they were able to source three total lots for the affected product.The additional two lot numbers identified are 250761365 and 251291365.A review of the device history record is in-progress.All information reasonably known as of 06 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 was defective or caused serious injury.
Event or Problem Description
It was reported that the t piece neonatal patient circuit kits were not registering a peep pressure.No harm or injury was reported as a result of this event.

• Brand Name: N/A
• Common Device Name: T-PIECE NEONATAL PATIENT CIRCUIT KIT, 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: 25094981
• Report Number: 3010838917-2026-00003
• Device Sequence Number: 5079384
• Product Code: BTL
• UDI-Device Identifier: 10190752135697
• UDI-Public: (01)10190752135697(10)WO40127
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K093913
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M1091365VS
• Device Catalogue Number: N/A
• Device Lot Number: WO40127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2026
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 06/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown