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

Model Number	18888-001
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged that the display is flickering and appears to be attempting to cycle power.The device was turned off by pressing and holding the standby/on button for an extended period.Complainant did not indicate that there was any patient involvement during the reported malfunction.
Additional Manufacturer Narrative
Some information was not provided and is unknown; therefore, a complete udi cannot be provided.Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Additional Manufacturer Narrative
The device was returned to the zoll fa lab for further evaluation.During the evaluation, several functional and physical issues were identified related to the unit's setup, operation, and internal configuration.Upon powering the device on in normal mode, a hardware fault (hw fault) error occurred.This was traced to a non-functioning fan and physical damage to the fan guard and filter housing.Visual inspection of the device revealed that the upper boot and three screws were missing, along with a finish washer.Additionally, the fan blade exhibited visible bending and scratches and was clearly displaced from the other blades.The external condition of the unit showed signs of significant physical damage.Removal of the soft side revealed gouges along the side of the unit, further indicating that the device had been subjected to force or mishandling.A known good fan was installed into the device and the device powered on with no issues.The hw fault error was not triggered with the known good fan installed; therefore, the root cause of the failure is determined to be due to the damaged fan.

• 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 drive; palm springs, CA 92262
• MDR Report Key: 22312462
• Report Number: 3013421741-2025-01609
• Device Sequence Number: 12964782
• Product Code: CBK
• UDI-Device Identifier: 10190752115279
• UDI-Public: (01)10190752115279
• 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
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2025

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: 06/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 08/18/2025
• 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