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

Model Number	525DS
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
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 had evidence of melting around the base rear cabinet and compressor box.There was no report or evidence of illness, serious injury or medical treatment associated with the complaint.The device was returned for evaluation.The device was found to have thermal damage to the base, compressor box and the bottom of the front and rear covers.The unit was found to be very dirty and had a very musty odor during operation.The intake hose was disconnected from the intake of the compressor and the spring had fallen out.Damaged screw bosses were observed throughout the unit.This damage was likely caused by severe mishandling of the unit.The usage log, which includes data past the last 14.7 hours of operation, showed that higher than normal temperatures were reached during operation since the intake hose was disconnected from the compressor, the compressor would have drawn in the heated air within the unit which would have caused the compressor to operate at a higher temperature and elevate the internal air temperature of the unit.Prior investigation of root causes for this warping issue has determined that the conditions necessary to create this type of thermal event are outside the acceptable operating and storage conditions for this device.The mishandling of the unit that caused the intake tubing disconnect failure and/or continual operation of the unit outside of the acceptable operating conditions is likely the cause of the thermal event.

• Brand Name: DEVILBISS 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 ; 5169954600
• MDR Report Key: 22141586
• Report Number: 2515872-2025-00015
• Device Sequence Number: 7356136
• Product Code: CAW
• UDI-Device Identifier: 00885304000846
• UDI-Public: (01)00885304000846
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K-071397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2025

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: 525DS
• Device Catalogue Number: 525DS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2022
• 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