MAUDE Adverse Event Report: INOGEN, INC. INOGEN ONE G3; GENERATOR, OXYGEN, PORTABLE

Catalog Number IO-300

Device Problem Insufficient Information (3190)

Patient Problem Low Oxygen Saturation (2477)

Event Date 12/23/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported by a patient that during an appointment with their respiratory therapist, their inogen® one g3 oxygen concentrator turned off and became unresponsive.The patient also reported that the respiratory therapist placed them on clinic provided oxygen while their backup oxygen was retrieved from home.No further information is available at this time.However, an investigation is currently ongoing and inogen® will file a supplemental report once the investigation has concluded.

Event Description

The patient reported to the fda via the self filed report # mw5092995 the following: 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.

• Brand Name: INOGEN ONE G3
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): INOGEN, INC.; 1225 commerce drive; richardson, tx
• Manufacturer (Section G): INOGEN, INC.; 326 bollay dr.; goleta, ca
• Manufacturer Contact: john anderson ; 1225 commerce drive; richardson, tx ; 7294120
• MDR Report Key: 9917947
• MDR Text Key: 208344134
• Report Number: 3015238204-2020-00001
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032818
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: IO-300
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR