MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-13 for INOGEN ONE G3 OXYGEN CONCENTRATOR 10-300 manufactured by Inogen, Inc..
[179786058]
My husband and i were at the pulmonologist in the afternoon and his inogen one g3 portable oxygen concentrator stopped working properly, giving an o2 delivery error and no oxygen. The respiratory therapist tried several ways to get the machine going but nothing worked. She connected him to one of their tanks so that i could drive home and back - a 40 min round trip drive - to get one of his continuous oxygen tanks provided by (b)(6) as the therapist stated he could not travel the 15-20 mins home in the car without any oxygen without ending up in the hosp or possibly dying. All of this is particularly pertinent because of inogen repeatedly providing us with potentially defective machines even though the company was aware of the problem. Please see the attached summary of our full complaint against the company. This incident is #14 in the listed events but we had another potentially life threatening episode with an earlier replacement model of the inogen one g3 that they sent us. This complaint is for my husband who must use oxygen 24/7 and who purchased the inogen one g3 for flexibility and convenience in leaving the home and to be able to travel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092995 |
| MDR Report Key | 9711304 |
| Date Received | 2020-02-13 |
| Date of Report | 2020-02-03 |
| Date of Event | 2019-12-23 |
| Date Added to Maude | 2020-02-14 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INOGEN ONE G3 OXYGEN CONCENTRATOR |
| Generic Name | GENERATOR, OXYGEN, PORTABLE |
| Product Code | CAW |
| Date Received | 2020-02-13 |
| Model Number | 10-300 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INOGEN, INC. |
| Brand Name | INOGEN ONE G3 OXYGEN CONCENTRATOR |
| Generic Name | GENERATOR, OXYGEN, PORTABLE |
| Product Code | CAW |
| Date Received | 2020-02-13 |
| Model Number | 10-300 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | INOGEN, INC. |
| Brand Name | INOGEN ONE G3 OXYGEN CONCENTRATOR |
| Generic Name | GENERATOR, OXYGEN, PORTABLE |
| Product Code | CAW |
| Date Received | 2020-02-13 |
| Model Number | 10-300 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | INOGEN, INC. |
| Brand Name | INOGEN ONE G3 OXYGEN CONCENTRATOR |
| Generic Name | GENERATOR, OXYGEN, PORTABLE |
| Product Code | CAW |
| Date Received | 2020-02-13 |
| Model Number | 10-300 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 4 |
| Device Event Key | 0 |
| Manufacturer | INOGEN, INC. |
| Brand Name | INOGEN ONE G3 OXYGEN CONCENTRATOR |
| Generic Name | GENERATOR, OXYGEN, PORTABLE |
| Product Code | CAW |
| Date Received | 2020-02-13 |
| Model Number | 10-300 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 5 |
| Device Event Key | 0 |
| Manufacturer | INOGEN, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-13 |