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

Model Number	18888-201
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: a third party service technician evaluated the ventilator and found that the unit was alarming "high peep"and "low peep" during use.As a resolution,the solenoid manifor was replaced.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
It was reported to vyaire medical problem with the laptop 1200 ventilator in which a defective solenoid manifold is causing high and low peep (positive end-expiratory pressure) alarms during use.Furthermore, there was no patient harm reported associated with the event.
Additional Manufacturer Narrative
Results of investigation: vyaire medical was not able to verify the customer complaint.The suspect device was returned for investigation.Vyaire received solenoid manifold assembly pn 18528-001 sn (b)(6).A visual inspection of assembly was performed and found no indications of damage, misuse, or contamination.Assembly was leak tested according to solenoid manifold test procedure 18282-001 leakage tests 7 through 9 were performed according to procedure and were found to be within the = 0.5cmh2o/min specification.Solenoid manifold was then installed onto fixture id ltvsol13 for automated testing.Test results found solenoid manifold passing on all counts.Proceeded to install solenoid manifold into a known good top-level ltv 1200 system.Ltv unit was set on adult default settings and allowed to run on adult default settings, peep was set to 5cmh2o for approx.30 mins and observed no circuit related errors, no high or low peep alarms present.The reported complaint was unable to be duplicated.Manifold assembly was leak tested according to test procedures, as well as through automated testing and was found to be within specifications.Assembly was also installed into a known good ltv system and was unable to observe any peep alarms during operation.Manifold assembly was found to be performing as intended.Solenoid manifold assembly pn 18528-001 sn (b)(6) will be scrapped.
Additional Manufacturer Narrative
H11: correction.D4: model#, g4: pma/510k.The supplemental report has corrected the model# to 18888-201 and pma/510k to k083688.

• Brand Name: LTV 1200 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: 18321402
• Report Number: 2021710-2023-18520
• Device Sequence Number: 17901057
• Product Code: CBK
• UDI-Device Identifier: 00845873002696
• UDI-Public: (01)00845873002696
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K083688
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/13/2023

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: 18888-201
• Device Catalogue Number: 18888-201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/07/2024; 06/20/2024
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 03/04/2024; 06/20/2024
• 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