VELA VENTILATOR 16532-02

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-11-29 for VELA VENTILATOR 16532-02 manufactured by Vyaire Medical.

MAUDE Entry Details

Report Number2021710-2019-11073
MDR Report Key9391958
Report SourceFOREIGN
Date Received2019-11-29
Date of Report2019-11-12
Date of Event2019-11-12
Date Mfgr Received2019-11-12
Device Manufacturer Date2016-03-21
Date Added to Maude2019-11-29
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 ContactSTANLEY TAN
Manufacturer Street22745 SAVI RANCH PKWY
Manufacturer CityYORBA LINDA CA 92887
Manufacturer CountryUS
Manufacturer Postal92887
Manufacturer Phone7149193324
Manufacturer G1VYAIRE MEDICAL
Manufacturer Street22745 SAVI RANCH PKWY
Manufacturer CityYORBA LINDA CA 92887
Manufacturer CountryUS
Manufacturer Postal Code92887
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVELA VENTILATOR
Generic NameVENTILATOR, CONTINUOUS, FACILITY USE
Product CodeCBK
Date Received2019-11-29
Model NumberVELA
Catalog Number16532-02
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerVYAIRE MEDICAL
Manufacturer Address22745 SAVI RANCH PKWY YORBA LINDA CA 92887 US 92887


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-29

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