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

Model Number	525KS
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	10/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Devilbiss healthcare was notified of an incident involving an oxygen concentrator by the french regulatory agency (ansm), that during use, the oxygen concentrator did not alarm, the end user's oxygen saturation dropped to 60%, and the end user became cyanotic.The medical emergency service was called to assist and the end user's oxygen saturation quickly corrected when oxygen was provided.The user manual contraindications state: "the device is not intended to be life supporting or life sustaining.The devilbiss 5 liter oxygen concentrator may be contraindicated in patients at risk of experiencing serious adverse health consequences resulting from a temporary loss of function." devilbiss healthcare is investigating the issue and will file an update if additional information becomes available.
Additional Manufacturer Narrative
Devilbiss healthcare evaluated the device and found that the main pcb (printed circuit board) was defective.When the device was powered on, there was no audible alarm, no visual alarm, and the pcb was not logging hours.There is no damage or burns on the main pcb.Thermal damage was noted on the compressor mounts at the base of the unit, as well as on the external plastic near the mounts.

• 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: 23594380
• Report Number: 2515872-2025-00037
• Device Sequence Number: 9532460
• Product Code: CAW
• UDI-Device Identifier: 00885304000976
• UDI-Public: (01)00885304000976
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2026

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?: Yes
• Device Model Number: 525KS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2020
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown