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

Model Number VELA

Device Problems Device Operates Differently Than Expected (2913); Improper Device Output (2953)

Patient Problem No Patient Involvement (2645)

Event Date 09/19/2017

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 unit's delivered tidal volumes are out of specifications.The customer performed troubleshooting, but the issue was not resolved.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

The suspect ventilator main printed circuit board assembly (pcba) was returned to vyaire and evaluated.The reported complaint was confirmed and duplicated.The root cause was assigned to pressure transducer failure.

• 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: 6962062
• MDR Text Key: 90565032
• Report Number: 2021710-2017-06813
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• 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: 03/27/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2013
• 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