MAUDE Adverse Event Report: VEGA TECHNOLOGIES INC. DRIVE; NEBULIZER

Model Number	18081
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a nebulizer by the patient, who stated that the "nebulizer caught on fire and he immediately pulled the power cord and threw the nebulizer out the door." there was no report or evidence of illness, injury or medical treatment associated with the complaint.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: NEBULIZER
• Manufacturer (Section D): VEGA TECHNOLOGIES INC.; yangwu district; dalang town; dongguan, guangdong 52378 9; CH 523789
• MDR Report Key: 15419206
• Report Number: 2438477-2022-00069
• Device Sequence Number: 17768978
• Product Code: CAF
• UDI-Device Identifier: 00822383504131
• UDI-Public: 00822383504131
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/14/2022
• Report Date (Section F): 09/14/2022

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: 18081
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• Date Report to Manufacturer: 09/21/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/14/2022