MAUDE Adverse Event Report: INOGEN, INC G4 BATTERY

Model Number	BA-400
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A patient reported that the battery of their g4 4-cell device was lasting only 25 minutes when fully charged, leading to concerns about the device's functionality, the patient was contacted multiple times.During the third contact, the patient shared that after attaching the unit, the strap broke, and within 20 minutes, the battery lost power.Both audible and visual alarms were active at the time.She switched to an alternative oxygen supply but still experienced shortness of breath.As a result, she went to the hospital and was admitted for four days, receiving treatment with medications, breathing treatments, and supplemental oxygen.Following her discharge, the patient reported that she was doing fine, though she continued to experience some difficulty breathing due to her medical condition.She remains on oxygen 24/7 at level 5 and did not receive a replacement unit.No ongoing complications from the event were noted.
Additional Manufacturer Narrative
Patient stated that the battery was only lasting 25 minutes, a replacement unit is being provided.

• Brand Name: G4 BATTERY
• Common Device Name: G4 BATTERY
• Manufacturer (Section D): INOGEN, INC; 600 shiloh rd; plano TX 75074
• Manufacturer Contact: kevin ford ; 600 shiloh rd; plano, TX 75074
• MDR Report Key: 21688581
• Report Number: 3004672275-2024-00086
• Device Sequence Number: 18496809
• Product Code: CAW
• UDI-Device Identifier: 00817131020117
• UDI-Public: (01)00817131020117
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: BA-400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown