MAUDE Adverse Event Report: DEVILBISS HEALTHCARE DEVILBISS 5L 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	03/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Devilbiss healthcare was notified of an incident involving an oxygen concentrator by the provider, who reported that the device was overheating.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 device was found to have evidence of thermal damage to the sides and front of the compressor box.Evidence of mishandling was present throughout the device, such as multiple broken screw bosses, broken plastic on the compressor box and an inoperable fan.The inoperable fan resulted in multiple high gas temperature errors during use.There was no evidence of an electrical fault and all components in the gas path were found undamaged.Functional testing of the device indicated the device was operational and within specifications.The root cause of the thermal event cannot be determined with certainty with the information and evidence provided.Prior investigations of root causes for similar 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.Continual operation of the unit outside of acceptable operating conditions, without the fan being functional, is likely the cause of the thermal event.Since the alarm system was functioning properly and multiple high gas temperature errors were logged, the user would have been alerted to the high temperature failure mode.

• Brand Name: DEVILBISS 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: 21700356
• Report Number: 2515872-2025-00011
• Device Sequence Number: 12710163
• Product Code: CAW
• UDI-Device Identifier: 00885304000846
• UDI-Public: (01)00885304000846
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2025

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: 11/27/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2020
• 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