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	10/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to vyaire medical problem with the laptop 1200 ventilator a persistent o2 (oxygen) pressure low alarm.Furthermore, there was no patient harm reported associated with the event.
Additional Manufacturer Narrative
H10: vyare medical was not able to verify the reported issue.The suspect device was returned for evaluation.Vyaire received ltv unit p/n 18888-201-99, s/n (b)(6).A visual inspection was performed and found unit missing bottom boot cover.No damages, signs of misuse or contamination were noted.A 50psi oxygen source and ac power was connected to unit and powered on.Customer settings were resumed, and unit was allowed to ventilate while observing for anomalies.Fio2 was set to 100%, an external o2 analyzer was connected at patient/gas outlet.O2 delivery was found to be delivering within specification at 95.5%.O2 unlet pressure was measured via rt xdcr data menu.With o2 line disconnected and open to ambient, o2 psi on ltv measured -0.04psi (spec 0 ±0.5psig).With 50psi applied to inlet port, ltv unit displayed 50.01psi (spec 50psi ±2psig).An event trace was performed and found several o2 low alarms.Per ltv operator¿s manual 32341-001, the o2 inlet pressure low alarm is set to activate at less than 35 psig.All triggered events occurred as expected when psi was below the 35psi threshold.System power was cycled into user mode and allowed to cycle on customer settings overnight in attempt to duplicate failure, no abnormal events were noted.O2 supply pressure was lowered and verified alarm triggers at the correct psi.The reported complaint was unable to be duplicated.A review of event trace confirmed low o2 alarms occurring, however ltv vent was found to be performing as expected.Alarms were triggered due to supplied o2 source being below the 35psi threshold.50psi was applied to unit during testing, no abnormal events were noted during evaluation.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
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 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: 18208784
• Report Number: 2021710-2023-18428
• Device Sequence Number: 7402023
• Product Code: CBK
• UDI-Device Identifier: 10190752115637
• UDI-Public: (01)10190752115637
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 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): 11/27/2023

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: 11/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2023
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 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