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 06/13/2018

Event Type  malfunction  

Manufacturer Narrative

Vyaire file identification: (b)(4).Any additional information received from the customer will be included in a follow-up report.The customer reported the suspected main printed circuit board assembly (pcba) is available for analysis and a return good authorization has been issued.At this time, vyaire has not received the suspected main pcba for evaluation.

Event Description

The customer reported while using the vela ventilator; the device displays transducer fault 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 identified the root cause of the reported issue was due to the pt802 to have recorded faults in the events log and to have failed calibration.This issue will be internally investigated within vyaire.

• 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: 7655884
• MDR Text Key: 112996425
• Report Number: 2021710-2018-09034
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• 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: 16532-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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