MAUDE Adverse Event Report: DEVILBISS HEALTHCARE DEVILBISS 5L OXYGEN CONCENTRATOR; GENERATOR, OXYGEN, PORTABLE

Model Number	525DS
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	01/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Devilbiss healthcare received a report involving an oxygen concentrator by the end user's daughter who reported the concentrator emitted a popping sound and subsequently ignited the nasal cannula.According to the information provided, the cannula tubing caught fire, and the flame traveled upward along the tubing that was laying on the end user's leg, resulting in third degree burns to the end user's upper thigh.The reporter indicated that there were no open flames, smoking materials, or other obvious external ignition sources present at the time of the event.Following the injury, the patient was evaluated at a burn center and later continued treatment at home.The device provider replaced the concentrator following the incident.Multiple attempts have been made to retrieve the affected unit for investigation; however, these attempts have been unsuccessful, and the device has not been returned to devilbiss for evaluation.Devilbiss healthcare will file an update if additional information becomes available.

• Brand Name: DEVILBISS 5L OXYGEN CONCENTRATOR
• 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: 24444850
• Report Number: 2515872-2026-00006
• Device Sequence Number: 16005508
• Product Code: CAW
• UDI-Device Identifier: 00885304000846
• UDI-Public: (01)00885304000846
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K071397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/25/2026

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
• Device Catalogue Number: 525DS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 02/25/2026
• 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
• Patient Age: 75 YR
• Patient Sex: Male