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

Model Number VELA

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 05/31/2018

Event Type  malfunction  

Manufacturer Narrative

Vyaire medical file identification: (b)(4).Any additional information received from the customer will be included in a follow-up report.The customer reported the suspect main printed circuit board (pcb) component is available for analysis and a return good authorization (rga) has been issued.At this time, vyaire medical has not received the suspect main printed circuit board (pcb) component for evaluation.In the event that the device is received for evaluation or additional information is received, a follow-up report will be submitted.

Event Description

The customer reported an unresolved transducer fault, motor fault and vent inoperative alarms on this ventilator device.The customer determined it was associated with the turbine transducer on the main printed circuit board (pcb).The customer stated no patient issue was associated with this event.

Manufacturer Narrative

Results of investigation: a vyaire failure analysis lab technician was able to verify the customer's reported issue.Bench testing revealed pt 800 transducer failed.

• Brand Name: VELA
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 north riverwoods blvd; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL INC.; palm springs CA 92262
• Manufacturer Contact: mindy faber ; 26125 north riverwoods blvd; mettawa, IL 60045 ; 8727570116
• MDR Report Key: 7652406
• MDR Text Key: 112849785
• Report Number: 2021710-2018-09033
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K093094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VELA
• Device Catalogue Number: 16532-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2013
• 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