MAUDE Adverse Event Report: VYAIRE MEDICAL INC. LTV 2150 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	LTV 2150 VENTILATOR
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).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 was received.
Event or Problem Description
The customer reported to vyaire medical that the lap top ventilator 2150 delivered tidal volume exceeding the high limit.Set at 500ml: low 450 high 500 measured 553ml.At this time, there is no information regarding patient involvement associated with the reported event.

• Brand Name: LTV 2150 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 12018251
• Report Number: 2021710-2021-14075
• Device Sequence Number: 17210705
• Product Code: CBK
• UDI-Device Identifier: 10190752139206
• UDI-Public: (01)10190752139206(11)20190620
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2021

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 2150 VENTILATOR
• Device Catalogue Number: 22685-006
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 06/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1