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

Model Number	LTV 1200 SERVICE REPAIR
Medical Device Problem Code	No Pressure (2994)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Vyaire medical file indentification: (b)(4).H3: 81 other - currently the suspect device has not been returned for evaluation.A root cause cannot be determined.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : currently, the device has not been received for evaluation.
Event or Problem Description
It was reported to vyaire medical the pressure support is "not working" on this unit.The unit was on a patient, no patient harm.
Additional Manufacturer Narrative
Device evaluation update: g3, g6, h2, h3, h6, and h11: the reported problem was confirmed through vyaire's failure analysis lab.The log file analysis tool was utilized and duplicated during functional check.An isolated problem of improper settings during set up.The rise time and/ or high pressure alarm limit were not set appropriately.

• Brand Name: LTV 1200 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 north riverwoods blvd,; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 8477865998
• MDR Report Key: 18992314
• Report Number: 2021710-2024-18942
• Device Sequence Number: 3037706
• Product Code: CBK
• UDI-Device Identifier: 10190752115279
• UDI-Public: (01)10190752115279
• Combination Product (Y/N): N
• 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
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LTV 1200 SERVICE REPAIR
• Device Catalogue Number: 18888-001-99
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2010
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown