MAUDE Adverse Event Report: DEVILBISS HEALTHCARE DEVILBISS; GENERATOR, OXYGEN, PORTABLE

Model Number	125D
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Brain Injury (2219); Convulsion/Seizure (4406)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Devilbiss healthcare evaluated the device involved in the event.Based on the assessment, the device was found to be fully operational and producing and delivering oxygen within specification at setting 3, which is the setting that was used by the customer.The alarm system was found to be working correctly and would have alerted the customer to any issues that may have occurred during use.
Event or Problem Description
Devilbiss healthcare was notified of an incident involving a portable oxygen concentrator by the home oxygen provider who stated that the "patient stated she was in a personal truck and went to get out and had a seizure and fell out." there were no other injuries associated with the reported incident.The patient told the provider that she sought medical attention, and claims a physician advised her "she has a brown spot on her brain." the patient is concerned the portable concentrator may have contributed to the event.Devilbiss healthcare has not received a report from the patient's physician.Devilbiss healthcare is requesting the return of the device for inspection and will file an update if additional information becomes available.

• Brand Name: DEVILBISS
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): DEVILBISS HEALTHCARE; 100 devilbiss drive; somerset PA 15501
• Manufacturer (Section G): DEVILBISS HEALTHCARE; 100 devilbiss drive; somerset PA 15501
• Manufacturer Contact: jess bohrer ; 100 devilbiss drive; somerset, PA 15501 ; 5169984600
• MDR Report Key: 23423621
• Report Number: 2515872-2025-00035
• Device Sequence Number: 18187388
• Product Code: CAW
• UDI-Device Identifier: 00885304022237
• UDI-Public: (01)00885304022237
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K172648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 125D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2022
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Female