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

Model Number	LTV 1200
Medical Device Problem Code	Failure to Auto Stop (2938)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported to vyaire medical that device was auto-cycling while on a patient on the lap top ventilator 1200.The customer confirmed there was no patient harm associated with the reported event.
Additional Manufacturer Narrative
Results of investigation: vyaire medical received the device for evaluation.A visual inspection was performed and found unit has visible wear from normal usage.No other indications of damage, misuse, or contamination.Ltv unit was connected to ac power.Event trace and post were retrieved, event trace showed multiple low dis, high dis (circuit disconnect), high f1 (auto-cycle) alarms, beginning on (b)(6) 2023 until last date of usage on (b)(6) 2023.Unit was received with sprint pack batteries fully depleted.Internal battery low ¿ below 11 volts the reported complaint was able to be duplicated.Unit was opened and inspected.A high and low flow transducer port leak test was performed and found high flow port leak rate to be out of specification.Failure was confirmed on ltv manifold test fixture detecting a leak at solenoid 4.Additional problem(s): sprintpack li-ion battery failed to charge.A battery duration test was performed on internal battery and was found to be performing below expectations.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: LTV 1200 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 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 ; 2402760001
• MDR Report Key: 18432552
• Report Number: 2021710-2024-18598
• Device Sequence Number: 7780920
• Product Code: CBK
• UDI-Device Identifier: 00845873000364
• UDI-Public: (01)00845873000364
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 01/02/2024

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 1200
• Device Catalogue Number: 18888-001-99
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2023
• Supplement Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 01/18/2024
• 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