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

Model Number	VELA
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Any additional information received from the customer will be included in a follow-up report.At this time, the suspect device has not been returned for evaluation.Therefore, no root cause could be determine yet.
Event or Problem Description
The customer reported that vela comp d shows transducer alarm fault.There is no patient involvement in this reported event.
Additional Manufacturer Narrative
Results of investigation: the vyaire failure analysis laboratory received the suspect component and performed a failure investigation.The reported complaint was able to be confirmed but not duplicated.Transducer pt802 has recorded faults on the event log but successfully calibrated.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: VELA VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL.; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 9723471
• Report Number: 2021710-2020-11414
• Device Sequence Number: 18924151
• Product Code: CBK
• UDI-Device Identifier: 10846446005431
• UDI-Public: (01)10846446005431(11)20081013
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K093094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VELA
• Device Catalogue Number: 16532-01
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 07/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1