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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL VELA VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE
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VYAIRE MEDICAL VELA VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number VELA
Device Problem Device Sensing Problem (2917)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/29/2023
Event Type  malfunction  
Event Description
It was reported to vyaire medical that the vela ventilator alarmed motor fault alarm.The customer confirmed that there is no patient involvement associated with this reported event.
 
Manufacturer Narrative
Vyaire medical 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.H3 other text : device not returned yet.
 
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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
sandra valencia
510 technology drive
irvine, CA 92618
8477865998
MDR Report Key18369018
MDR Text Key331072717
Report Number2021710-2023-18545
Device Sequence Number1
Product Code CBK
UDI-Device Identifier10846446001358
UDI-Public(01)10846446001358
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093094
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberVELA
Device Catalogue Number16600
Was Device Available for Evaluation? Yes
Date Manufacturer Received11/29/2023
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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