MAUDE Adverse Event Report: DEVILBISS HEALTHCARE LLC DEVILBISS; OXYGEN CONCENTRATOR

Model Number	146-525DS
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Devilbiss healthcare was notified of a complaint involving an oxygen concentrator by an end user's son, who stated there was an "explosion and black smoke." there was no report or evidence of illness, injury or medical treatment associated with the complaint.Devilbiss is currently investigating the incident, including attempting to gain additional information regarding the reported event and retrieve the device for examination.An update will be filed if additional information becomes available.
Additional Manufacturer Narrative
**udi related data quality updates only** the previously submitted report had lacking or incorrect information in sections d1 brand name, d4 udi and catalog number and h4 device manufacture date.These sections have been updated with corrected information.

• Brand Name: DEVILBISS
• Common Device Name: OXYGEN CONCENTRATOR
• 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; ste 210; somerset, PA 15501 ; 5169984600
• MDR Report Key: 17878303
• Report Number: 2515872-2023-00087
• Device Sequence Number: 7760676
• Product Code: CAW
• UDI-Device Identifier: 10612479248158
• UDI-Public: (01)10612479248158(21)B222250596DS
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Repair,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 146-525DS
• Device Catalogue Number: 525DS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2022
• 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
• Patient Sex: Unknown