VMAX VMAX ENCORE 22D 777405-101

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-06-19 for VMAX VMAX ENCORE 22D 777405-101 manufactured by Vyaire Medical.

MAUDE Entry Details

Report Number2021710-2019-10389
MDR Report Key8713841
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-06-19
Date of Report2018-11-19
Date of Event2018-11-19
Date Mfgr Received2018-11-19
Device Manufacturer Date2006-06-01
Date Added to Maude2019-06-19
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 INC.
Manufacturer Street1100 BIRD CENTER DRIVE
Manufacturer CityPALM SPRINGS CA 92262
Manufacturer CountryUS
Manufacturer Postal Code92262
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVMAX
Generic NameCALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
Product CodeBTY
Date Received2019-06-19
Model NumberVMAX ENCORE 22D
Catalog Number777405-101
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
101. Other 2019-06-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.