INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR IO-300

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 2019-10-03 for INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR IO-300 manufactured by Inogen Inc..

MAUDE Entry Details

Report Number3015238204-2019-56789
MDR Report Key9153602
Report SourceFOREIGN
Date Received2019-10-03
Date of Report2019-10-02
Date of Event2019-07-03
Date Mfgr Received2019-09-03
Date Added to Maude2019-10-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. MARA KORSUNSKY
Manufacturer Street326 BOLLAY DRIVE
Manufacturer CityGOLETA CA 93117
Manufacturer CountryUS
Manufacturer Postal93117
Manufacturer Phone8055620629
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR
Generic NameINOGEN ONE G3 OXYGEN CONCENTRATOR
Product CodeCAW
Date Received2019-10-03
Returned To Mfg2019-09-26
Model NumberIO-300
Catalog NumberIO-300
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerINOGEN INC.
Manufacturer Address1225 COMMERCE DRIVE RICHARDSON TX 75088 US 75088


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-10-03

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