MAUDE Adverse Event Report: VYAIRE MEDICAL, INC LTV; VENTILATOR BREATHING CIRCUIT, SINGLE-USE

Model Number	29657-001
Medical Device Problem Codes	Device Alarm System (1012); Gas Output Problem (1266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use on a 55-year-old female, the circuit caused the ventilator to inappropriately set off an alarm and caused rapid triggering, not allowing the patient to take normal breaths.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.The customer's report is against two circuits from the same lot number and it is noted that the circuits were disposed of and are not available for evaluation.
Additional Manufacturer Narrative
The investigation is still in process.The circuits related to the reported event were discarded by the user and are unable to be returned for evaluation.
Additional Manufacturer Narrative
Correction: d4.The device was not returned to zoll medical corporation.The circuits were reported to be new and exhibited no visible damage or abnormalities, and were discarded by the customer prior to reporting and were therefore unavailable for evaluation.As the patient circuits were not returned and no additional evidence of the reported issue was provided, the supplier for the customers circuits were contacted to perform a device history record (dhr) review.The device history record confirmed that the complete lot was manufactured, inspected, and released on 03apr2025 in accordance with internal procedures, and no manufacturing discrepancies or related issues were identified.Based on the unavailability of the patient circuits for evaluation and the results of the supplier's dhr review, we are unable to determine a definitive root cause.

• Brand Name: LTV
• Common Device Name: VENTILATOR BREATHING CIRCUIT, SINGLE-USE
• Manufacturer (Section D): VYAIRE MEDICAL, INC; 26125 n. riverwoods blvd; mettawa IL 60045
• Manufacturer Contact: mindy faber ; 1100 bird center dr.; palm springs, CA 92262
• MDR Report Key: 24746817
• Report Number: 3013421741-2026-00127
• Device Sequence Number: 9422502
• 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: IL
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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: Other
• Device Model Number: 29657-001
• Device Catalogue Number: 29657-001
• Device Lot Number: 004309572
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 55 YR
• Patient Sex: Female