MAUDE Adverse Event Report: VYAIRE MEDICAL, INC LTV 1200 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number LTV 1150

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/24/2018

Event Type  malfunction  

Manufacturer Narrative

Any additional information provided by the customer will be included in a follow up report.Results of investigation: a vyaire third party service technician was able to verify the customer's reported issue.Bench testing revealed a malfunctioning flow valve.The service technician replaced the flow valve and the reported issue was resolved.The device passed all testing and met all vyaire manufacturer specifications.Vyaire received the malfunctioning flow valve for further evaluation.The component is currently being evaluated by the failure analysis lab.When the results of investigation become available, a follow up report will be submitted.

Event Description

It was reported to vyaire that the lap top ventilator 1150 was delivering higher volume than what was set while connected to a patient.The customer stated that the device was set to deliver 500mls, the unit would deliver 560mls.The customer confirmed that there was no patient harm associated with the reported event.

Manufacturer Narrative

The vyaire failure analysis laboratory received the suspect component flow valve p/n 10019 and performed a failure investigation.The reported issue was not duplicated in the laboratory setting.No corrective or preventive action is required.The uut was found to function normally p/n 10019 was not the cause of the failure.

Event Description

It was reported to vyaire that the lap top ventilator 1150 was delivering higher volume than what was set while connected to a patient.The customer stated that the device was set to deliver 500mls, the unit would deliver 560mls.The customer confirmed that there was no patient harm associated with the reported event.

• Brand Name: LTV 1200 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL, INC; 22745 savi ranch parkway; yorba linda CA 92887
• MDR Report Key: 7530202
• MDR Text Key: 108782280
• Report Number: 2031702-2018-02185
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K060647
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LTV 1150
• Device Catalogue Number: 18984-006-99
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2018
• Initial Date Manufacturer Received: 03/24/2018
• Initial Date FDA Received: 05/21/2018
• Supplement Dates Manufacturer Received: 09/05/2018
• Supplement Dates FDA Received: 11/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention