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

Model Number	525DS
Medical Device Problem Code	Sparking (2595)
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 an incident involving an oxygen concentrator by the provider, who stated that the power cord is sparking.Upon visual examination of the returned unit, a cut in the insulation was observed that exposed the wires within the line cord.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 was no report or evidence of illness, serious injury or medical treatment associated with the complaint.
Additional Manufacturer Narrative
Drive devilbiss healthcare evaluated the device and based on the condition of the device as returned, the line cord had a cut in the outer insulation and the black wire within was completely severed.The interior of the unit was found to be very dusty, and the plastic was damaged in multiple locations.The rear cover door had a broken support rib and the left side fastener hole in the rear cover was cracked.The compressor box also had a large crack on the left side.This damage was likely caused by a sharp impact to the left side of the unit.The customer complaint of "power cord sparking" can be attributed to the damaged line cord.The hot wire in the line cord was found to be open and a deep cut in the insulation under the strain relief was observed.It is likely that the strain relief cut into the line cord and severed the hot wire which would have caused sparking.

• 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: 22099649
• Report Number: 2515872-2025-00014
• Device Sequence Number: 8354128
• 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,Followup
• Report Date (Section B): 08/05/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown