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

Model Number	ASSY, LTV 2200, W-ACCY, ENGLISH IN
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: com-(b)(4).H3:02-the suspect device was returned and evaluation is anticipated but not yet begun.Once a final investigation is complete, a follow-up report will be submitted.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
The customer reported to vyaire medical problem with the laptop 2200 ventilator in which the fio2 (fraction of inspired oxygen) via external analyzer was much lower than the fio2 that was set on the vent.Furthermore, there was no patient involvement associated with the event.
Additional Manufacturer Narrative
Results of investigation: the suspect device has been returned for evaluation.Vyaire received ltv2 unit p/n 22690-001-99 (b)(6).A visual inspection was performed and found scuffing on rear weldment, fan filter in need of replacement.Also found left side of chassis slightly bent at turbine inlet filter location.No other damages, signs of misuse or contamination were noted.Ltv unit was then connected to ac power source and powered on.Accepted end users¿ last known settings and allowed unit to cycle for approximately 40 minutes.Customer settings had fio2 set to 100%.A calibrated o2 analyzer was connected to unit and blending accuracy was measured.Found unit to be delivering below specification at 81-82%.System power was cycled and powered into service mode.The reported fio2 complaint was able to be duplicated and isolated to faulty flow valve causing o2 delivery inaccuracies.Flow valve calibration was also unable to be performed.Flow valve was replaced with a known good assembly and was able to verify blending accuracy using service manual testing and specifications.

• Brand Name: LTV 2200 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL, INC; 26125 n. 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: 18055534
• Report Number: 2021710-2023-18346
• Device Sequence Number: 6962126
• Product Code: CBK
• UDI-Device Identifier: 10190752139220
• UDI-Public: (01)10190752139220
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2023

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: ASSY, LTV 2200, W-ACCY, ENGLISH IN
• Device Catalogue Number: 22690-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2023
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 12/14/2023
• 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