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

Model Number	525KS
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Devilbiss healthcare was notified of an incident involving an oxygen concentrator by the french agency (antadir), which reported that the concentrator emitted black smoke and had evidence of deformation to the casing at the main socket, including the power cord.There was no report or evidence of illness, serious injury or medical treatment associated with the complaint.Devilbiss healthcare is attempting to retrieve the unit for evaluation and will file an update when additional information becomes available.
Additional Manufacturer Narrative
Devilbiss healthcare was previously notified of an incident involving an oxygen concentrator by the french agency (antadir) which reported that the concentrator emitted black smoke and had evidence of deformation on the casing at the main socket, including the power cord.The device was returned for evaluation.Thermal damage was limited to the back of the device near the iec connector and adjacent components.The iec housing was not returned with the device for unknown reasons.The metal connection tabs from the iec connector were still connected to the wire harness within the device and the front prongs were visible.It is likely that the front prongs of the iec connector were not making a proper connection to the back prongs that are attached to the wire harness within the device.This caused high resistance leading to excessive heat and thermal damage.The female end of the line cord that plugs into the front of the iec connector was thermally damaged.The insulation on multiple adjacent wires had melted away, exposing the conductors within the device and the base of the device was damaged around the thermal event.The line cord was tested and found to operate properly.There was no thermal damage observed to any other internal components and all internal components in the gas path were found to be undamaged.Based on the device evaluation, the thermal event is most consistent with a high resistance electrical connection at the iec connector interface.The examination indicated that the front prongs of the iec connector were not fully engaged with the rear prongs connected to the internal wire harness, which can result in increased electrical resistance and localized heat generation.This condition is consistent with the observed thermal damage.The findings suggest that the electrical connection was not fully seated or secured at the time of use, which may have contributed to the inadequate contact between the connector interfaces.Excessive heat buildup at this interface led to the thermal damage observed on the device.

• Brand Name: DEVILBISS HEALTHCARE 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: 22737232
• Report Number: 2515872-2025-00025
• Device Sequence Number: 9103935
• Product Code: CAW
• UDI-Device Identifier: 00885304000976
• UDI-Public: (01)00885304000976
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K071397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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: 525KS
• Device Catalogue Number: 525KS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2024
• 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