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

Model Number LTV 1100

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 04/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Any additional information provided by the customer will be included in a follow up report.A vyaire certified service technician was able to verify the customer's reported issue.Bench testing revealed that the turbine assembly seized.The service technician replaced the turbine assembly and the reported issue was resolved.The device passed all testing and met all vyaire manufacturer specifications.

Event Description

It was reported to vyaire that the lap top ventilator 1100 experienced no tidal volume delivery.The customer confirmed that there was no patient involvement associated with the reported issue.

• Brand Name: LTV 1100 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL, INC; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): VYAIRE MEDICAL, INC; 17400 medina road; suite 100; plymouth MN 55447
• Manufacturer Contact: avery foster ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 7549503
• MDR Text Key: 109494882
• Report Number: 2031702-2018-02193
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101643
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/29/2018

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
• Device Operator: Health Professional
• Device Model Number: LTV 1100
• Device Catalogue Number: 21102-001-99
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/30/2018
• Initial Date FDA Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1