MAUDE Adverse Event Report: INOGEN INOGEN OXYGEN CONCENTRATOR

Device Problems Device Inoperable (1663); Defective Component (2292); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2017

Event Type  malfunction  

Event Description

Caller reported that on (b)(6) 2017, she bought an inogen oxygen concentrator which did not work.A tech from inogen determined that the concentrator was defective.There was some kind of powder coming out of it.A replacement concentrator of the same type was sent which still did not work.She has made repeated calls to the mfr's customer care to request for a refund but they do not respond to her calls.

• Brand Name: INOGEN OXYGEN CONCENTRATOR
• Type of Device: OXYGEN CONCENTRATOR
• Manufacturer (Section D): INOGEN
• MDR Report Key: 7174568
• MDR Text Key: 96834315
• Report Number: MW5074464
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 78 YR