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

Model Number	18888-201
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H4: device manufacture date is unknown.D4: udi#: udi was not provided and is unknown.Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Event or Problem Description
Complaintant alleged that before use, the device was experiencing a clicking noise near the o2 inlet.Complainant did not indicate that there was any patient involvement in the reported malfunction.
Additional Manufacturer Narrative
Updated sections: d9, g6, h2, h3, h6, and h11 the suspect device was returned for evaluation, and the customers reported complaint was replicated and verified; the clicking sound was coming from the o2 blender, specifically from the actuation of internal components.This sound is consistent with normal operation and does not indicate a fault or abnormal behavior.The acoustic profile of the clicking was consistent with typical operational sounds and was not excessively loud.The part will be moved to factory service then to process in accordance with factory service procedures.

• 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 ; plo 1 jalan firma 1 kawasan; perindustrian tebrau 1; johor bahru ; MY
• MDR Report Key: 22370619
• Report Number: 3013421741-2025-01622
• Device Sequence Number: 4617482
• Product Code: CBK
• UDI-Device Identifier: 10190752115637
• UDI-Public: (01)10190752115637
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 06/10/2025

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?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 09/15/2025
• 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