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

Model Number	525DS
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	05/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive medical was notified of an incident involving an oxygen concentrator by the provider who reported that the device powered up with a yellow light, then it alarmed and the red light came on, and the end user was unsure if the oxygen concentrator shut down.The end user reported that the portable oxygen system was not working properly.The paramedics were called and the end user was taken to the hospital.The product's instruction manual states: "the device is not intended to be life supporting or life sustaining.When the unit is turned on, all three lights (service required, low oxygen and normal oxygen) on the front panel will illuminate briefly and an audible signal will briefly alarm confirming that the leds and audible signal are functioning properly.The unit will then operate in start up mode with the low oxygen light lit until a normal oxygen level is achieved, at which time the normal oxygen light will remain lit.The start up may take up to 15 minutes.If any of the lights on the front panel do not illuminate or the audible alarm does not sound, this indicates the alert system is not functioning properly.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." as part of its complaint review and evaluation process, drive medical 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: 25361959
• Report Number: 2515872-2026-00013
• Device Sequence Number: 13444151
• Product Code: CAW
• UDI-Device Identifier: 00885304000846
• UDI-Public: (01)00885304000846
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/02/2026

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2024
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female