MAUDE Adverse Event Report: VYAIRE MEDICAL, INC LTV 1200 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	11/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received in the failure analysis lab for evaluation.The device was visually inspected and there were no indications of damage or misuse during inspection.The device was run with the last known customer settings and was left to run for approximately 19 hours with no hardware faults occurring during that time.The device event trace was reviewed and there were instances of a fan flt occurring around the event date; however, no instances were found on the date provided by the end user.These faults would appear as a hw fault on the device during operation.The device continued to perform as expected throughout the evaluation and successfully passed all functional testing.Based on the information provided, it was not clear how close the device was positioned relative to the mri system at the time of the reported event; therefore, it cannot be determined whether the device was operated outside the specified mri conditions.
Event or Problem Description
The customer reported that while the unit was being transported into an mri room, they observed that the vent was indicating an hw fault alarm.They secured the patient in a bag, and the patient was subsequently transferred to another ltv.No harm to the patient was reported.
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.

• Brand Name: LTV 1200 VENTILATOR
• Common Device Name: 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: 23718156
• Report Number: 3013421741-2025-01852
• Device Sequence Number: 10431092
• Product Code: CBK
• UDI-Device Identifier: 00845873002696
• UDI-Public: (01)00845873002696
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K083688
• 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): 11/14/2025

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: 11/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2019
• 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