MAUDE Adverse Event Report: DEVILBISS HEALTHCARE LLC DEVILBISS; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number	5650C
Medical Device Problem Codes	Decrease in Pressure (1490); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Devilbiss healthcare was notified of an incident involving a nebulizer compressor by a service provider, who reported that the unit had low pressure during use, smelled burned and that treatment time took too long.When the end-user saw smoke emitting from the device, she stopped the device and completed her treatment with her back-up compressor.There was no report of patient harm or injury.Devilbiss is in the process of facilitating the return of the product for inspection and will update this report should any additional information become 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.The device manufacturer date in section h4 was incorrect or missing in the previous report therefore h4 has been updated with the correct information.

• Brand Name: DEVILBISS
• Common Device Name: NEBULIZER (DIRECT PATIENT INTERFACE)
• 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: 19016028
• Report Number: 2515872-2024-00018
• Device Sequence Number: 3809695
• Product Code: CAF
• UDI-Device Identifier: 00885304000884
• UDI-Public: (01)00885304000884(21)C7007446
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K923888
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2025

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: 5650C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2021
• 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