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

Model Number VELA

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Apnea (1720)

Event Date 03/06/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).A vyaire field service representative (fsr) went onsite to evaluate the customer's device.The fsr replaced the display printed circuit board, main board and tubing.User verification tests and calibrations were performed on the device.The device did not pass all tests and did not meet manufacturing specifications.It was determined that turbine should be replaced.If additional information is received or a final evaluation is performed, then a supplemental report will be submitted.

Event Description

The customer reported that their vela ventilator alarmed disconnect and was not ventilating while on the patient.The patient had apnea and cpr was performed on the patient.

Manufacturer Narrative

Additional field service findings have been added.A vyaire field service representative (fsr) went onsite to evaluate the customer's device.The fsr was able to confirmed the circuit disconnect, transducer fault, and low peak inspiratory pressure alarms at the time of the event.The fsr noted there was no ventilator inoperable alarms and the following setting were used on a patient: prvc a/c, rate 12, volume 450 ml, insp time 09.Seconds, peep 5, flow trig 2, and o2 100%.The fsr determined the most likely cause of the issue is the main printed circuit board assembly.The fsr replaced the main pcba, turbine, tubing, muffler, base, and exhalation valve assembly.The fsr performed the opertaional verification procedure and reported the device meets factory specifications.

Event Description

The customer reported while using the vela ventilator; the device displays circuit disconnect alarms and was not ventilating.The issue occurred during patient-use; the customer reported her heart stopped and cpr was performed.At this time, it is unknown whether or not additional patient consequence are associated with event.

• 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: 7394495
• MDR Text Key: 104247455
• Report Number: 2021710-2018-07654
• 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: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 16600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2018
• Initial Date FDA Received: 04/03/2018
• Supplement Dates Manufacturer Received: 07/26/2018
• Supplement Dates FDA Received: 01/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2007
• 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