MAUDE Adverse Event Report: VYAIRE MEDICAL, INC LTV; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	18888-001
Medical Device Problem Code	Failure to Cycle (1142)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.Device manufacture date is unknown.
Event or Problem Description
It was reported that the vent is not cycling, and the turbine is not operational.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
The device was not returned for evaluation; however, technical support provided troubleshooting to the biomed at the customer site.Throughout the troubleshooting process, the customer replaced both the motor board and the power board, yet the problem continued.Upon internal examination, the customer indicated that the turbine was seized.The device was due for its 30k preventive maintenance (pm).As a result, the customer ordered a 30k pm kit, which includes a new turbine.It was requested that the defective turbine be returned for further evaluation; however, at this time the component has not been received.

• Brand Name: LTV
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY 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: 23199569
• Report Number: 3013421741-2025-01732
• Device Sequence Number: 9433881
• Product Code: CBK
• UDI-Device Identifier: 10190752115279
• UDI-Public: (01)10190752115279
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K060647
• 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): 09/12/2025

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: 18888-001
• Device Catalogue Number: 18888-001
• 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: 09/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/02/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown