MAUDE Adverse Event Report: VYAIRE MEDICAL INC. LTV; PATIENT CIRCUIT W/O PEEP, 22MM, SPU

Model Number	29657-001
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Decreased Respiratory Rate (2485)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that once in use, the patient stated that the circuit appeared to cause the ventilator to malfunction, resulting in rapid triggering and preventing the patient from taking normal breaths.Both circuits with matching lot number 0004309572 produced the same ventilator response.The patient replaced the circuits with a backup circuit of the same item id (29657001) but a different lot number, after which the ventilator ceased rapid triggering.The patient reported that the ventilator had not exhibited similar issues previously.No harm was reported as a result of this event.The patient discarded the circuits after the event.
Additional Manufacturer Narrative
The product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 18 mar 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 complaint- (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 is defective, caused, or contributed to a serious injury.

• Brand Name: LTV
• Common Device Name: PATIENT CIRCUIT W/O PEEP, 22MM, SPU
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 north riverwoods blvd; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL; productos urologos de mexico s; no. 85 parque indust.mexicali; baja california, 21397 ; MX 21397
• Manufacturer Contact: candacy bush ; 2710 northridge dr. nw, suite a; grand rapids, MI 49544
• MDR Report Key: 24627606
• Report Number: 1314417-2026-00013
• Device Sequence Number: 9201409
• Product Code: CBK
• UDI-Device Identifier: 10190752115934
• UDI-Public: (01)10190752115934(10)0004309572(11)250403(17)300403
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K101643
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2026

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: Lay User/Patient
• Device Model Number: 29657-001
• Device Catalogue Number: 29657-001
• Device Lot Number: 0004309572
• 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: 02/16/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown