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

Model Number	LTV 1200
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire file identification : (b)(4).A third party service technician evaluated the ventilator and replaced the oxygen blender.
Event or Problem Description
The customer reported that ltv 1200 is delivering high o2 (60% greater than 72%).At this time, there is no information regarding patient involvement associated with the reported event.

• Brand Name: LTV 1200 SERVICE REPAIR, JAPAN
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 10353885
• Report Number: 2031702-2020-03615
• Device Sequence Number: 11352806
• Product Code: CBK
• UDI-Device Identifier: 00845873002641
• UDI-Public: (01)00845873002641(11)20170126
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060647
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2020

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: 18888-006-99
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2020
• Initial Report FDA Received Date: 07/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1