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

Model Number	1025DS
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Devilbiss healthcare was notified of an incident involving an oxygen concentrator when it received medwatch report 261616-2024-0001, which stated that "caregiver reported fire caused by electric outlet however because of the patient's history of smoking, non-compliance with safety interventions, location of burns, and the fact the windows blew out we believe that perhaps the pt took the oxygen off and put it under her bottom to smoke and did not turn off the oxygen.Fire department reports are currently unavailable." the fire department reportedly disposed of the concentrator.Devilbiss healthcare has requested that the fire department provide a copy of the fire report.Devilbiss healthcare is currently investigating the incident.An update will be filed if additional information becomes available.
Additional Manufacturer Narrative
The previously submitted report had lacking or incorrect information in section d4 udi.Section d4 has been updated with the correct information.

• Brand Name: DEVILBISS HEALTHCARE
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): DEVILBISS HEALTHCARE LLC; 100 devilbiss drive; somerset PA 15501
• Manufacturer (Section G): DEVILBISS HEALTHCARE LLC; 100 devilbiss drive; somerset PA 15501
• Manufacturer Contact: jess bohrer ; 100 devilbiss drive; somerset, PA 15501 ; 5169984600
• MDR Report Key: 19427774
• Report Number: 2515872-2024-00027
• Device Sequence Number: 8010915
• 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,Followup
• Report Date (Section B): 12/29/2024

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: 1025DS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2024
• Supplement Date Received by Manufacturer: 12/29/2024
• Initial Report FDA Received Date: 05/30/2024
• Supplement Report FDA Received Date: 12/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2023
• 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: 72 YR
• Patient Sex: Female