MAUDE Adverse Event Report: VYAIRE MEDICAL, INC LTV 2200 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	LTV 2200 SERVICE REPAIR
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).H3: 81 other - at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : device was not yet returned.
Event or Problem Description
It was reported to vyaire medical that the ltv 2200 o2 blending percentage had failed at 90%.The result was 96.1% while the maximum specification is 95%.Furthermore, there was no patient associated with the reported event.
Additional Manufacturer Narrative
Results of investigation: vyaire medical was unable to confirm and duplicate the issue.The (unit under test) was functioning with no issues or faults.Move the unit to factory service.O2 blender to be replaced as a precautionary measure.Replace material as required, rework to current configuration, recalibrate, and retest per specifications and standards.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: LTV 2200 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL, INC; 26125 n. riverwoods blvd.; mettawa IL
• Manufacturer (Section G): VYAIRE MEDICAL, INC PALM SPRINGS; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 18499832
• Report Number: 2021710-2024-18655
• Device Sequence Number: 7948637
• Product Code: CBK
• UDI-Device Identifier: 10190752139220
• UDI-Public: (01)10190752139220
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2024

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: Health Professional
• Device Model Number: LTV 2200 SERVICE REPAIR
• Device Catalogue Number: 22690-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 04/01/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown