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

Model Number	18888-001
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Event or Problem Description
Customer stated that the unit will not turn on.There was no patient involvement reported.
Additional Manufacturer Narrative
Correction - d1 and d4.The device was returned for evaluation, and the reported malfunction was confirmed as the device would not power on while using the internal battery.Once the device was connected to ac power, the device powered on.It was observed during evaluation that the device had been opened by the customer, and the original internal battery had been replaced with a different internal battery.Upon further inspection, it was identified that the fuse was blown, which is consistent with the installation of an incompatible battery.Based on testing and inspection results, it was determined that the installation of the incompatible internal battery caused fuse f1 to blow, resulting in the device being unable to power on when operating on internal battery power.

• 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 ; 1100 bird center dr.; palm springs, CA 92292
• MDR Report Key: 24020682
• Report Number: 3013421741-2026-00005
• Device Sequence Number: 18777952
• Product Code: CBK
• UDI-Device Identifier: 10190752115279
• UDI-Public: (01)10190752115279(11)220608
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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): 12/19/2025

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: 12/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 02/27/2026
• 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