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

Model Number	ASSY, LTV 2200, W-ACCY
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to vyaire medical that the ltv 2200 vent repeated shutdown and starts-up while it was working on patient.The vent started just after it was turned on, but shutdown right away.No patient harm.
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4) h3: 81 other - at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Additional Manufacturer Narrative
Results of investigation: the reported complaint was confirmed.The ltv2 power board p/n 22620-001 s/n (b)(6) was found to have a failed component.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: LTV 2200 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 ; 8477865998
• MDR Report Key: 19504974
• Report Number: 2021710-2024-19113
• Device Sequence Number: 4071692
• Product Code: CBK
• UDI-Device Identifier: 00845873000364
• UDI-Public: (01)00845873000364(11)20180120
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K101643
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2024

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
• Device Catalogue Number: 22690-006
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown