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

Model Number	1025DS
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Chronic Obstructive Pulmonary Disease (COPD) (2237)
Date of Event	02/03/2024
Type of Reportable Event	Death
Event or Problem Description
Drive devilbiss healthcare was notified of an incident allegedly involving an oxygen concentrator by a letter from an attorney, which states the oxygen concentrator malfunctioned while in use and the end user passed away.The end user suffered from severe chronic obstructive pulmonary disease.Drive devilbiss healthcare is currently investigating the incident, including attempting to inspect the device in cooperation with the attorney.
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.The serial number is unknown and thus cannot be updated.In addition, the manufacturing date is derived from the serial number and thus is blank as well.

• Brand Name: DEVLIBISS 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: 19082200
• Report Number: 2515872-2024-00019
• Device Sequence Number: 18082482
• Product Code: CAW
• UDI-Device Identifier: 00885304022466
• UDI-Public: (01)00885304022466
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2024

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?: Yes
• 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: 03/20/2024
• Supplement Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (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 Sex: Male