MAUDE Adverse Event Report: VYAIRE MEDICAL LTV 1100 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	LTV 1100
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).A third party service technician evaluated the ventilator.The unit failed the leak test and the service technician replaced the solenoid manifold to correct the issue.
Event or Problem Description
The customer reported that the lap tap ventilator 1100 keeps alarming high pressure and high peak.At this time, there is no information regarding patient involvement associated with the reported event.

• Brand Name: LTV 1100 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, ca
• MDR Report Key: 10505323
• Report Number: 2031702-2020-03666
• Device Sequence Number: 11546833
• Product Code: CBK
• UDI-Device Identifier: 00845873000203
• UDI-Public: (01)00845873000203(11)20040520
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K101643
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2019

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 1100
• Device Catalogue Number: 10130-99
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 09/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1