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

Model Number VELA

Device Problems Device Displays Incorrect Message (2591); Calibration Problem (2890); Device Operates Differently Than Expected (2913); Output Problem (3005)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 06/06/2018

Event Type  Injury  

Manufacturer Narrative

Vyaire file identification: (b)(4).Any additional information received from the customer will be included in a follow-up report.At this time, the suspect component is not available for return.Due to the part not being available to be returned, no further evaluation can be completed at this time.

Event Description

The customer reported while using the vela ventilator; the device displays ventilator inoperable alarms.The customer determined the most likely cause of the reported event is the main printed circuit board assembly.The customer reported there is no patient involvement associated with the event.

Manufacturer Narrative

Results of investigation: the vyaire failure analysis laboratory received the suspect component for investigation.An investigation was performed and reported event was able to be confirmed and duplicated.The pt 800 has failed.This issue will be internally investigated within vyaire.

Event Description

The customer reported while using the vela ventilator; the high pressure alarm went off during the patient use.The high flow was discharged from the expiratory sensor.And " vent inop" alarm went off.The customer reported the hospital staff stopped using the unit.The branch, sensor and filter were replaced but the error was not resolved.Imi field staff confirmed the alleged event.

• Brand Name: VELA VENTILATOR
• 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: 7650749
• MDR Text Key: 112739958
• Report Number: 2021710-2018-09032
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K093094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/19/2019

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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VELA
• Device Catalogue Number: 16532-12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2011
• 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
• Patient Outcome(s): Required Intervention