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

Model Number VELA VENTILATOR

Device Problem Poor Quality Image (1408)

Patient Problem No Information (3190)

Event Date 07/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).At this time, vyaire has not received the suspect device/component for evaluation.

Event Description

The customer reported that their vela ventilator had a dim and blurred screen.The customer did not report any information regarding patient involvement, it is currently unknown.

Manufacturer Narrative

Results of investigation: the vyaire medical failure analysis laboratory received the suspect component, a vela main front panel assembly, and evaluated the component.Visual inspection found that a wire has broken free of the lcd video connector.An evaluation of the component duplicated the reported issue and isolated the issue to damaged lcd video cable p/n: (b)(4).

• Brand Name: VELA 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; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: kristin graf ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 6775779
• MDR Text Key: 82108762
• Report Number: 2021710-2017-06433
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093094
• 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,Followup
• Report Date: 04/03/2018

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: VELA VENTILATOR
• Device Catalogue Number: 16600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2017
• Initial Date FDA Received: 08/08/2017
• Supplement Dates Manufacturer Received: 03/19/2018
• Supplement Dates FDA Received: 04/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2011
• 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