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

Device Problems Device Emits Odor (1425); Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 03/14/2017

Event Type  malfunction  

Event Description

The vent was alarming.When i walked in the pt's room the vent read "vent inop" and was no longer ventilating for the pt.I also smelled a burnt smell coming from the vent.(b)(4).

• Brand Name: AVEA
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL, INC.; 1100 bird center dr.; palm springs CA 92262
• MDR Report Key: 6621628
• MDR Text Key: 76975901
• Report Number: 6621628
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/10/2017
• Event Location: Hospital
• Date Report to Manufacturer: 05/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR