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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 Thermal Decomposition of Device (1071)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/29/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The customer reported a burning mark on the main board , as well as the cable from the power supply to the main board.At this time, the suspect device has not been returned for evaluation.Therefore, no root cause could be determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
 
Event Description
The customer reported device had a burning smell on powering up on the vela ventilator.The customer reported that there was no patient involvement associated with the reported event.
 
Manufacturer Narrative
Result of investigation: the vyaire failure analysis lab (fa lab) was able to duplicate the reported problem.The vela, replacement, cf2 main pcba was received as damaged no further actions are needed.
 
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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
MDR Report Key10899706
MDR Text Key218149186
Report Number2021710-2020-12823
Device Sequence Number1
Product Code CBK
UDI-Device Identifier70846446001442
UDI-Public(01)70846446001442
Combination Product (y/n)N
PMA/PMN Number
K093094
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 06/09/2021
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
Device Operator Health Professional
Device Model NumberVELA
Device Catalogue Number16532-02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/09/2021
Initial Date Manufacturer Received 10/29/2020
Initial Date FDA Received11/25/2020
Supplement Dates Manufacturer Received06/09/2021
Supplement Dates FDA Received06/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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