MAUDE Adverse Event Report: VYAIRE MEDICAL, INC LTV 1150 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	18984-001
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation received the device for investigation.The device went through 37.9 hours of run in utilizing the customer settings.During this time, the unit had no issues or faults.A review of the device event trace was also performed for the date of the reported incident.The event trace review showed normal operation on the event date with no faults found.
Event or Problem Description
Complainant alleged that during use on a patient, the device was not blowing air.First responders placed patient on transport ventilator and was sent to hospital.Complainant indicated that there was no adverse effect to the patient due to the reported issue.

• Brand Name: LTV 1150 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 ; 26125 n. riverwoods blvd; mettawa, IL 60045 ; 8333273284
• MDR Report Key: 21961152
• Report Number: 3013421741-2025-01555
• Device Sequence Number: 7273344
• Product Code: CBK
• UDI-Device Identifier: 00845873002726
• UDI-Public: (01)00845873002726
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K051767
• 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
• Report Date (Section B): 04/16/2025

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: 18984-001
• Device Catalogue Number: 18984-001
• 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: 04/16/2025
• Initial Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2016
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown