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

Device Problems Alarm Not Visible (1022); Insufficient Flow or Under Infusion (2182)

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 produced low oxygen and failed to alarm.In turn, the customer went to the hospital wherein the customer was hospitalized for shortness of breath.The customer was discharged until they received the replacement device.The customer stated that the issue was resolved.

• 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: 18419529
• MDR Text Key: 331685357
• Report Number: 3015238204-2023-00017
• 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: Other
• Type of Report: Initial
• Report Date: 12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• 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: 10/19/2023
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/24/2023
• 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