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

Model Number	LTV 1000
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).Any additional information received from the customer will be included in a follow-up report.Vyaire has not received the suspect device/component for evaluation.Therefore, no root cause could be determined yet.However, the customer replaced main power pcb to correct the issue.
Event or Problem Description
The customer reported that the assy ltv1000 w/access.(b)(6) ventilator shut down on internal battery after 10 mins, the unit does not turn on, the pigtail is broken and the fi fuse is burned.The customer confirmed that there was no patient involvement in this 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: 10146034
• Report Number: 2031702-2020-03499
• Device Sequence Number: 3426857
• Product Code: CBK
• UDI-Device Identifier: 00845873001750
• UDI-Public: (01)00845873001750(11)20000331
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051767
• 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): 05/15/2020

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 1000
• Device Catalogue Number: 10130J-99
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2020
• Initial Report FDA Received Date: 06/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1