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 |