VELA VENTILATOR 16532-00

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-03-31 for VELA VENTILATOR 16532-00 manufactured by Vyaire Medical.

MAUDE Entry Details

Report Number2021710-2020-11719
MDR Report Key9908531
Report SourceDISTRIBUTOR,FOREIGN
Date Received2020-03-31
Date of Report2020-02-24
Date of Event2020-02-24
Date Mfgr Received2020-02-24
Device Manufacturer Date2009-09-01
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. MINDY FABER
Manufacturer Street26125 N. RIVERWOODS BLVD.
Manufacturer CityMETTAWA, IL
Manufacturer CountryUS
Manufacturer Phone7570116
Manufacturer G1VYAIRE MEDICAL
Manufacturer Street1100 BIRD CENTER DRIVE
Manufacturer CityPALM SPRINGS, CA
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVELA VENTILATOR
Generic NameVENTILATOR, CONTINUOUS, FACILITY USE
Product CodeCBK
Date Received2020-03-31
Model NumberVELA
Catalog Number16532-00
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerVYAIRE MEDICAL
Manufacturer Address26125 N. RIVERWOODS BLVD. METTAWA, IL US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.