MAUDE Adverse Event Report: DEVILBISS HEALTHCARE DEVILBISS 10L OXYGEN CONCENTRATOR; GENERATOR, OXYGEN, PORTABLE

Model Number	1025DS
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/20/2025
Type of Reportable Event	Death
Event or Problem Description
Devilbiss healthcare was notified of an incident involving an oxygen concentrator by the provider who reported the device was not producing oxygen and the end user passed away.The device was returned for evaluation, and it was determined that the unit was functioning correctly and within specification (>87% oxygen concentration).While the oxygen sensing board was found to be slightly out of tolerance when tested at 10lpm, which resulted in the unit alarming for low oxygen even though the oxygen was within specification, the last usage log record indicated that the flow had been turned above 10lpm, contrary to the device's instructions for use, causing the oxygen concentration to drop.The most recent record in the usage log indicated that the flowrate was turned up to 17.9lpm.The device's instruction guide states: "a flow setting other than prescribed may affect the patient therapy.For prescriptions of 10 lpm, be sure the ball is centered on the 10-liter line.The ball should not touch the red line.Setting the flow higher than 10 may cause the oxygen purity level to drop.If the oxygen purity falls below the acceptable level: the green normal oxygen light will shut off, the yellow low oxygen light will illuminate, and an intermittent audible signal will sound.If you feel discomfort or are experiencing a medical emergency while undergoing oxygen therapy, seek medical assistance immediately to avoid harm." the device is not intended to be life supporting or life sustaining.Devilbiss healthcare will file an update if additional information becomes available.

• Brand Name: DEVILBISS 10L 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: 23770050
• Report Number: 2515872-2025-00041
• Device Sequence Number: 21486570
• Product Code: CAW
• UDI-Device Identifier: 00885304022466
• UDI-Public: (01)00885304022466
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1025DS
• Device Catalogue Number: 1025DS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2024
• 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: Death
• Patient Age: 69 YR
• Patient Sex: Unknown