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

Model Number	1025DS
Medical Device Problem Codes	Device Emits Odor (1425); Powder Leak (4069)
Health Effect - Clinical Code	Aspiration Pneumonitis (4455)
Date of Event	06/21/2025
Type of Reportable Event	Death
Event or Problem Description
Devilbiss healthcare was notified of an incident involving an oxygen concentrator by an attorney, who alleged that the device exploded and released a yellowish powder and an intense noxious odor.The end user allegedly suffered immediate respiratory distress and died shortly after.A review of our records indicated that a different end user reported the same device as alarming a month prior to this event, as a result of which it was returned to the dme provider for service.It is unclear at this time what service was performed on the device at that time.Devilbiss healthcare is currently investigating the incident, including arranging an inspection of the device through the attorney.An update will be filed if additional information becomes available.
Additional Manufacturer Narrative
Devilbiss healthcare has received photographic documentation of the oxygen concentrator from legal counsel.Upon review, the images indicate the presence of powder or particulate matter consistent with sieve material.This material appears to have migrated from the internal components of the device, likely through the exhaust vents located at the base of the unit.The observed condition suggests that, under certain circumstances, a sufficient quantity of sieve dust may escape the unit via these vents.Importantly, there is no indication of thermal damage, combustion, or any associated heat-related event.

• Brand Name: DRIVE 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: 22576408
• Report Number: 2515872-2025-00024
• Device Sequence Number: 15812267
• Product Code: CAW
• UDI-Device Identifier: 00885304022466
• UDI-Public: (01)00885304022466
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 10/13/2025

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: 1025DS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2023
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown