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

Model Number VELA CF COMP,DISS,GRN O2,TYPE K,ENG OVERLAY

Device Problems Mechanical Problem (1384); Device Emits Odor (1425); No Tactile Prompts/Feedback (4024)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/26/2023

Event Type  malfunction  

Event Description

It was reported to vyaire medical that the vela ventilator failed the touch screen calibration.Moreover, it was stated that there was an electronic smell from the front of the vent.There was no patient involved in this reported event.

Manufacturer Narrative

Vyaire file identification: (b)(4).H3: 81 other - at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information was received.H3 other text : device was not returned yet.

Manufacturer Narrative

Results of investigation: vyaire medical was able to verify the customer complaint.The suspect device was returned for investigation.Vyaire received vela cf comp,diss,grn o2,type k,eng overlay part number: 16532-00 serial number: (b)(6) visually inspected on uut (unit under test) assembly, there was physical damaged on top cover, cracked front panel, scratched screen, and missing screws.Powered the uut in ventilate mode where the unit showed vent inop, motor fault, and circuit disconnect alarms upon start-up.The uut was turned off and it was detected that it had a burning smell.Disassembled the uut to inspect pcba¿s, cables, connectors, and batteries.The capacitor on the battery tray part number: 16048 was found damaged.The main board was removed from the front panel assembly and connectors j16 & j17 were found burned.Installed a known good pcba vela main coldfire part number: 52850, no issues were found, the uut was tested, and was found to be functioning as intended.The reported complaint was confirmed and duplicated.This is isolated to a short on pcba, vela main coldfire part number: 52850 serial number: (b)(6).The returned vela cf comp,diss,grn o2,type k,eng overlay will be routed to the factory service to have install new pcba vela main coldfire part number: 52850 and then have assembly processed.The removed pcba vela mailn coldfire part number: 52850 serial number: (b)(6) will be scrapped in the fa lab.

• Brand Name: VELA VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618 ; 7607787281
• MDR Report Key: 17153450
• MDR Text Key: 317655378
• Report Number: 2021710-2023-17818
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10846446001419
• UDI-Public: (01)10846446001419
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VELA CF COMP,DISS,GRN O2,TYPE K,ENG OVERLAY
• Device Catalogue Number: 16532-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2024
• 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