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

Model Number	18888-001
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Event or Problem Description
It was reported that during a patient transport the device "stopped" while in use.There was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The device was not returned to zoll medical corporation for further evaluation; however, the event trace (device logs) were evaluated by technical support with the initial reporter.During the review, there were no hardware related alarms found during the reported operation period.Additional information has not been provided; therefore, we are unable to confirm the reported event or potential root cause.

• 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: 23033548
• Report Number: 3013421741-2025-01690
• Device Sequence Number: 15748465
• Product Code: CBK
• UDI-Device Identifier: 10190752115279
• UDI-Public: (01)10190752115279
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

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
• 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: 08/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 10/24/2025
• 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