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

Model Number	525DS
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During an internal review, devilbiss healthcare discovered that an mdr prepared in january 2022 was not successfully submitted.Upon discovery, devilbiss healthcare is submitting the report late.
Event or Problem Description
Devilbiss healthcare was notified of an incident involving an oxygen concentrator reported by the end user as not delivering oxygen.According to the information provided, the end user subsequently required hospitalization.No additional clinical details regarding the hospitalization were made available.The device involved in the incident was not returned to devilbiss healthcare for evaluation; therefore, no device analysis was conducted, and confirmation of the alleged device malfunction could not be performed.

• Brand Name: DEVILBISS HEALTHCARE 5L 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
• MDR Report Key: 24025920
• Report Number: 2515872-2026-00002
• Device Sequence Number: 10554925
• Product Code: CAW
• UDI-Device Identifier: 00885304000846
• UDI-Public: (01)00885304000846
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/09/2026

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
• Operator of Device: Lay User/Patient
• Device Model Number: 525DS
• Device Catalogue Number: 525DS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2022
• Initial Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2000
• 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: Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male