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

Model Number	1025DS
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Devilbiss healthcare was notified of an incident involving an oxygen concentrator by a third-party service center who stated that the compressor heats up.There was no report or evidence of illness, injury or medical treatment associated with the complaint.The third-party service center evaluated the device and found evidence of thermal damage to the plastic frame that the sieve bed and main circuit board were mounted to.The third-party service center replaced the plastic housing to address the issue.
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 device manufacturer date in section h4 was incorrectly submitted in the previous report.H4 has been updated with the correct information.
Additional Manufacturer Narrative
Devilbiss healthcare previously reported an incident involving an oxygen concentrator that was reported to devilbiss by a third-party service center, which stated that "the compressor heats up." there was no report or evidence of illness, injury or medical treatment associated with the complaint.The third-party service center evaluated the device and reported evidence of thermal damage to the plastic frame to which the sieve bed and main circuit board were mounted.The third-party service center replaced the plastic housing to address the issue.The device was returned to devilbiss for evaluation, where it was determined that in fact, the device had no evidence of thermal damage.All components within the gas path were found to be undamaged.There was no evidence of an electrical fault.All electrical connections were undamaged.The compressor plates were installed backwards, which made the unit run louder and vibrate.

• 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; 100 devilbiss drive; somerset PA 15501
• Manufacturer Contact: jess bohrer ; 100 devilbiss drive; somerset, PA 15501 ; 5169984600
• MDR Report Key: 19721915
• Report Number: 2515872-2024-00037
• Device Sequence Number: 15490809
• Product Code: CAW
• UDI-Device Identifier: 00885304022466
• UDI-Public: (01)00885304022466(21)A219170113DS
• 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,Followup
• Report Date (Section B): 02/06/2025

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: 1025DS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 12/30/2024; 01/27/2025
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 12/30/2024; 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2021
• 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
• Patient Sex: Unknown