MAUDE Adverse Event Report: Drive Medical DeVilbiss 5-liter oxygen concentrator; GENERATOR, OXYGEN, PORTABLE

Model Number	525DS
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive medical was notified of an incident involving an oxygen concentrator from a device provider's attorney regarding injury from a concentrator fire causing burns to the end user's face and throat.Drive medical is currently investigating the incident, including attempting to inspect the device.An update will be filed if additional information becomes available.

• Brand Name: DeVilbiss 5-liter 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: 50587111
• Report Number: 2515872-2026-00026
• Device Sequence Number: 15849707
• Product Code: CAW
• UDI-Device Identifier: 00885304000846
• UDI-Public: (01)00885304000846
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K071397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/03/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 525DS
• 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: Not provided
• Initial Report FDA Received Date: 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention; Other
• Patient Sex: Male