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

Model Number	525DS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Low Oxygen Saturation (2477)
Date of Event	04/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Devilbiss healthcare was notified of an incident involving and oxygen concentrator that displayed red lights, audibly alarmed during use, the end user was placed on a reserve back up oxygen system and was taken to the emergency room for low oxygen saturation and high blood pressure.The product's instructions for use state: the device is not intended to be life supporting or life sustaining' and 'if your unit loses electrical power or fails to operate correctly, the patient alert system will sound to signal you to switch to your reserve oxygen system and contact your devilbiss provider.' devilbiss healthcare has requested the return of the device for evaluation and will file an update if additional information becomes available.

• Brand Name: DEVILBISS
• 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: 25044882
• Report Number: 2515872-2026-00008
• Device Sequence Number: 16066621
• Product Code: CAW
• UDI-Device Identifier: 00885304000846
• UDI-Public: (01)00885304000846
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 04/07/2026
• Initial Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 227 KG