MAUDE Adverse Event Report: VYAIRE MEDICAL LTV 1000 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	LTV 1000
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire file identification: (b)(4).A third party service technician evaluated the ventilator.The technician applied 50.2 psi o2 and the ventilator monitored 50.2 psi.Low o2 pressure alarm occurred when input pressure was reduced to below 35 psi.In low pressure o2 source mode, hi o2 pressure alarm occured above 10 psi.Found unit will not achieve set pressure in pressure mode.The technician replaced the turbine.The ventilator passed tests and calibration.
Event or Problem Description
It was reported that the ltv1000 has problem with o2 delivery and it gives low o2 pressure alarm resulting in decreased o2 saturation once applied.At this time, there is no information regarding patient involvement associated with the reported event.

• Brand Name: LTV 1000 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 10354194
• Report Number: 2031702-2020-03563
• Device Sequence Number: 860391
• Product Code: CBK
• UDI-Device Identifier: 00845873000203
• UDI-Public: (01)00845873000203
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051767
• 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): 10/24/2018

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 1000
• Device Catalogue Number: 10130-99
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 08/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1