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

Model Number	525DS
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Devilbiss healthcare was notified of a device malfunction involving an oxygen concentrator by the provider, who stated that the power cord has exposed wires.The device is past its stated five-year use life.The instruction manual for this device includes warnings stating "improper use of the power cord and plugs can cause a burn, fire or other electric shock hazards.Do not use the unit if the power cord is damaged.Ensure the mains power cord is fully inserted into the concentrator connector (230 volt units) and the power cord plug is completely inserted into a fully functioning ac wall outlet.Failure to do so may cause an electrical safety hazard." there is no allegation of fire, sparks, or smoke.There was no report or evidence of illness, serious injury or medical treatment associated with the complaint.Devilbiss healthcare will file an update if additional information becomes available.

• Brand Name: DEVILBISS 5 LITER 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: 22478699
• Report Number: 2515872-2025-00021
• Device Sequence Number: 20818946
• Product Code: CAW
• UDI-Device Identifier: 00885304000846
• UDI-Public: (01)00885304000846
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2025

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2020
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown