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

Model Number	18888-001
Medical Device Problem Code	Failure to Run on Battery (1466)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
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.Some information was not provided and is unknown; therefore, a complete udi cannot be provided.
Event or Problem Description
Complainant alleged that the device will not run on internal battery.Complainant indicated that there was no patient involvement in the reported issue.
Additional Manufacturer Narrative
Updated sections: d4, g6, h2, h3, h4, h6, and h11.Visual inspection of the unit under test (uut) found no visible defects, damage or contamination.When the device was powered on, the charge status led illuminated red and remained in that state for over 10 minutes, suggesting that the internal battery was unable to accept a charge.Upon inspecting the internal battery, it was noted that the fuse was intact; however, both cells were found to be depleted.Subsequently, a known functional internal battery was installed for testing, and the uut was confirmed to operate within specifications.The unit was found to have a failed internal battery.

• 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: 22115793
• Report Number: 3013421741-2025-01590
• Device Sequence Number: 12551900
• Product Code: CBK
• UDI-Device Identifier: 10190752115279
• UDI-Public: (01)10190752115279(11)200914
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2020
• 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