MAUDE Adverse Event Report: VYAIRE MEDICAL, INC LTV 1200 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	18888-201
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
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.H4: device manufacture date is unknown.
Event or Problem Description
Customer stated that the unit alarmed with a hardware fault error message while being used on a patient but kept ventilating.There was no patient harm reported.
Additional Manufacturer Narrative
The device was returned to the zoll failure analysis lab (fa lab) for further evaluation.During the investigation it was noted that the reported issue was confirmed to have occurred based on event trace review; however, the issue could not be replicated during testing.During fa lab testing and normal operation of the unit, no hardware fault events were observed, and the device was found to be performing as intended.During evaluation, the external power and charge status green led indicators were observed to be dim and barely visible.As a corrective action, the main board will be replaced to address this condition.Correction - d1 brand name and d4 udi.

• Brand Name: LTV 1200 VENTILATOR
• 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: 23926757
• Report Number: 3013421741-2025-01904
• Device Sequence Number: 15659746
• Product Code: CBK
• UDI-Device Identifier: 00845873002696
• UDI-Public: (01)00845873002696
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 12/15/2025

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: 18888-201
• Device Catalogue Number: 18888-201
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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