MAUDE Adverse Event Report: DEVILBISS HEALTHCARE LLC DEVILBISS; NEBULIZER

Model Number	6910D-DR
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Devilbiss healthcare is the manufacturer of the device which is a nebulizer.We are awaiting return of the device for evaluation.A follow-up report will be submitted when additional data is available.We are filing this report in an over abundance of caution.The device was acquired one year ago.The user never noticed it overheating or a burning smell before.However, within the last week he noticed the noise level of the device increased.The device started smoking and caught on fire during the user's regular morning treatment.He changed the filters and updated the hoses as necessary.No injuries occurred nor did any property damage.

• Brand Name: DEVILBISS
• Common Device Name: NEBULIZER
• Manufacturer (Section D): DEVILBISS HEALTHCARE LLC; 100 devilbiss drive; somerset PA 11501
• MDR Report Key: 12543633
• Report Number: 2515872-2021-00009
• Device Sequence Number: 4460332
• Product Code: CAF
• UDI-Device Identifier: 00885304002529
• UDI-Public: 885304002529
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K031413
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 09/28/2021

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: 6910D-DR
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2021
• Initial Report FDA Received Date: 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1