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

Model Number	1025DS
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Devilbiss healthcare was notified of an incident involving an oxygen concentrator by the provider who stated that the oxygen concentrator was "shooting out fire" from the vents on the bottom of the device.This occurred after a routine filter change.There was no report or evidence of illness, serious injury or medical treatment associated with the complaint.The provider reported the device was operating in a dusty and tar filled smoker home.The device was returned for evaluation.Upon evaluation, the manufacturer found the wire harness to be severed.It is likely that the wire harness was not properly tucked at the rear of the unit or was dislodged during a sharp impact, which allowed it to rub against the compressor brackets.Over time this friction wore through the convoluted tubing and eventually the black and white wires.It is likely that arcing occurred as the black and white wires contacted the metal compressor bracket.However, no evidence of the unit shooting out fire from the grates' was observed as the foam and base showed no evidence of thermal damage or charring from flames or sparks.

• Brand Name: DEVILBISS HEALTHCARE 10L COMPACT 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: 22851584
• Report Number: 2515872-2025-00027
• Device Sequence Number: 14557650
• Product Code: CAW
• UDI-Device Identifier: 00885304022466
• UDI-Public: (01)00885304022466
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2025

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: 08/14/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2023
• 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