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	10/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 during patient use.Furthermore, there was no patient harm reported associated with the event.Unit was swapped out for a different device.
Additional Manufacturer Narrative
Results of investigation: vyaire medical was able to verify the reported issue.The suspect device was returned for investigation.Vyaire medical received ltv 2200 p/n 22690-001-99 s/n (b)(6) version 01.08.Visually inspected the unit and found screws and washers to be missing on both upper and bottom boots.Also normal use wear can be seen on the exterior of ventilator.Powered unit into service mode, downloaded/ reviewed power on self test (post) and events trace.Found no issues during review.Switched modes into service and allowed unit to warm up.Continued by removing and inspecting o2 blender assembly p/n 15079-001 s/n (b)(6) 0288 rev.Af, found no physical damage or signs of misuse.The reported fio2 problem was duplicated and isolated to o2 blender assembly p/n 15079-001 s/n (b)(6) , solenoid 1 output port on manifold is obstructed with dust/metal debris preventing o2 flow.Cause of dust metal debris is extended wear on solenoid plunger and solenoid body.

• 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: 18055442
• Report Number: 2021710-2023-18345
• Device Sequence Number: 12474918
• 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?: Yes
• 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: 11/29/2023
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 12/21/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown