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..
Report Number | 3015238204-2019-56789 |
MDR Report Key | 9153602 |
Report Source | FOREIGN |
Date Received | 2019-10-03 |
Date of Report | 2019-10-02 |
Date of Event | 2019-07-03 |
Date Mfgr Received | 2019-09-03 |
Date Added to Maude | 2019-10-03 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MS. MARA KORSUNSKY |
Manufacturer Street | 326 BOLLAY DRIVE |
Manufacturer City | GOLETA CA 93117 |
Manufacturer Country | US |
Manufacturer Postal | 93117 |
Manufacturer Phone | 8055620629 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR |
Generic Name | INOGEN ONE G3 OXYGEN CONCENTRATOR |
Product Code | CAW |
Date Received | 2019-10-03 |
Returned To Mfg | 2019-09-26 |
Model Number | IO-300 |
Catalog Number | IO-300 |
Operator | LAY USER/PATIENT |
Device Availability | R |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | INOGEN INC. |
Manufacturer Address | 1225 COMMERCE DRIVE RICHARDSON TX 75088 US 75088 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2019-10-03 |