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
The device was returned to the zoll failure analysis lab for investigation.Powered the unit into user mode resuming same patient settings, unit was ventilating normally without any alarms.Noticed that the ltv charge status remains red indicating an issue with internal battery.While the unit was ventilating, disconnected ac power, unit immediately shut down.Removed and inspected internal battery, found no physical anomalies.Battery was manufactured on 08/03/20.It is unknown when the battery was installed and is close to being 5 years old.The reported problem was confirmed through the event trace and duplicated during function check.Internal battery p/n 18608-001 l/n 2032 rev.D has failed and needs replacement due to lack of maintenance.The claim will be closed as device meets specification, as the device functioned as expected despite being used with a poorly maintained battery.Zoll recommends battery replacement as part of the 4-year preventive maintenance (pm), which the customer did not perform.
Event or Problem Description
Complaint alleged that before use, the device inappropriately shut down when unplugged.Complaint indicated that there was no patient involvement in the reported issue.

• 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: 22384882
• Report Number: 3013421741-2025-01634
• Device Sequence Number: 13025504
• Product Code: CBK
• UDI-Device Identifier: 00845873000364
• UDI-Public: (01)00845873000364
• 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): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2025

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?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 07/02/2025
• 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