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

Model Number	18888-001
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2025
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.D4: unique identifier (udi) # - unable to determine entire udi# as information was not provided.
Event or Problem Description
Complainant alleged that before use, the device experienced a hardware fault error.Complainant indicated that there was no patient involvement in the reported issue.
Additional Manufacturer Narrative
Additional information received indicates that the device was returned for further investigation.Visually inspected ltv unit, found no anomalies.Powered unit into service mode, downloaded/ reviewed power on self-test (post) and event trace which indicated some fan fault entries to be recorded causing the unit to alarm hw fault.Powered the unit into user mode where it ventilated normally without any faults.Unit continued to ventilate for 19 hours without any alarms.Removed bottom weldment and inspected components, found no anomalies.Cycled the power multiple times in effort to attempt to reproduce the hw fault.Ltv unit powered on normally each time.The reported problem was confirmed through the event trace but not duplicated during functional check.

• 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 ; 8333273284
• MDR Report Key: 22457652
• Report Number: 3013421741-2025-01628
• Device Sequence Number: 8156185
• Product Code: CBK
• UDI-Device Identifier: 10190752115279
• UDI-Public: (01)10190752115279
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 06/20/2025

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: 06/20/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 09/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2009
• 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