MAUDE Adverse Event Report: DEVILBISS HEALTHCARE DEVILBISS 10L OXYGEN CONCENTRATOR; GENERATOR, OXYGEN, PORTABLE

Model Number	1025DS
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Devilbiss healthcare was notified of an incident involving an oxygen concentrator by a third-party service center who reported the device was damaged by a fire, having evidence of a burnt front cover.There was no report or evidence of illness, serious injury or medical treatment associated with the complaint.The device was returned for evaluation.Upon evaluation, the thermal damage to the unit is concentrated to the front of the unit, at the humidifier recess cavity.The thermal event appears to have started external to the device causing charring on the back, side, and bottom of the humidifier recess.The metal outlet appears to have prevented fire ingress to the unit.The damage to the bottom of the humidifier cavity and charred pieces found there, was likely caused by the cannula hanging down from the plastic fitting that was connected to the outlet port.All internal components within the gas path were found to be undamaged.Functional testing of the unit indicated that it was operational and within specification (>87% oxygen concentration) at both 5 and 10lpm flow settings.The fan and alarm system were both found to be functional.An odor of cigarette smoke was coming from the unit during operation.It can be concluded that the thermal event did not initiate from the oxygen concentrator or propagate through the unit by way of the oxygen gas path.Since the damage was concentrated to the front of the unit, at the humidifier recess cavity, it is believed that the fire originated from an external source and traveled to the outlet port of the unit via the cannula tubing.The device contains several warnings against smoking during use, both on the product itself and in instructions for use.The on-product warnings include a large, clear "no smoking" icon, and a clear "no open flame" icon as well.The instructions for use warn against smoking during use in several places, in several languages, including the following verbiage: "oxygen causes rapid burning.Do not smoke while your oxygen concentrator is operating, or when you are near a person utilizing oxygen therapy.Smoking during oxygen therapy is dangerous and is likely to result in facial burns or death.Do not allow smoking within the same room where the oxygen concentrator or any oxygen carrying accessories are located.If you intend to smoke, you must always turn the oxygen concentrator off, remove the cannula and leave the room where either the cannula or mask or the oxygen concentrator is located.If unable to leave the room, you must wait 10 minutes after you have turned off the oxygen concentrator before smoking.Oxygen makes it easier for a fire to start and spread.Do not leave the nasal cannula or mask on bed coverings or chair cushions if the oxygen concentrator is turned on but not in use.The oxygen will make the materials flammable.Turn the oxygen concentrator off when not in use to prevent oxygen enrichment.Keep the oxygen concentrator and cannula at least 2 m (6.5 feet) from hot, sparking objects or naked sources of flame.Open flames during oxygen therapy are dangerous and are likely to result in fire or death.Do not allow open flames within 2 m (6.5 feet) of the oxygen concentrator or any oxygen carrying accessories.Drive devilbiss oxygen concentrators are equipped with a fire mitigating outlet fitting that prevents propagation of fire into the unit." the manufacturer concludes, based on the information provided, that the oxygen concentrator did not malfunction, and the use error of smoking likely caused the adverse.

• Brand Name: DEVILBISS 10L 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: 21756307
• Report Number: 2515872-2025-00012
• Device Sequence Number: 15865066
• Product Code: CAW
• UDI-Device Identifier: 00885304022466
• UDI-Public: (01)00885304022466
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/02/2025

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: 1025DS
• Device Catalogue Number: 1025DS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2023
• 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