MAUDE Adverse Event Report: Drive Medical Drive Medical iGO2 oxygen concentrator; GENERATOR, OXYGEN, PORTABLE

Model Number	125D-XB
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2026
Type of Reportable Event	Malfunction

• Brand Name: Drive Medical iGO2 oxygen concentrator
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): Drive Medical; 100 devilbiss drive; somerset PA 15501
• Manufacturer (Section G): Drive Medical; 100 devilbiss drive; somerset PA 15501
• Manufacturer Contact: jess bohrer ; 100 devilbiss drive; somerset, PA 15501 ; +1(516)998-4600
• MDR Report Key: 50084556
• Report Number: 2515872-2026-00020
• Device Sequence Number: 10219742
• Product Code: CAW
• UDI-Device Identifier: 00885304032045
• UDI-Public: (01)00885304032045
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K172648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 125D-XB
• Device Catalogue Number: 125D-XB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2023
• 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
• Patient Sex: Unknown