MAUDE Adverse Event Report: INOGEN, INC. INOGEN AT HOME

Device Problems Failure to Power Up (1476); Infusion or Flow Problem (2964)

Patient Problem Low Oxygen Saturation (2477)

Event Date 10/09/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation; however, the evaluation was not yet completed.The investigation is ongoing, and a supplemental report will be submitted if additional information is provided by the user facility.

Event Description

The customer reported to inogen, that the device alarmed and shutdown.Reportedly, the customer could not receive replacement unit in a timely manner.Therefore, the customer's pulmonologist informed the customer to go to the emergency room.In turn, the customer was admitted to the hospital wherein the customer received oxygen for chronic obstructive pulmonary disease and discharged two days later.Reportedly, the customer is feeling better.

• Brand Name: INOGEN AT HOME
• Type of Device: INOGEN AT HOME
• Manufacturer (Section D): INOGEN, INC.; 600 shiloh rd.; plano TX 75074
• Manufacturer Contact: falon whitfield ; 600 shiloh rd.; plano, TX 75074 ; 9726165673
• MDR Report Key: 18401811
• MDR Text Key: 331688054
• Report Number: 3015238204-2023-00015
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00817131020148
• UDI-Public: (01)00817131020148
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2023
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/12/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization