MAUDE Adverse Event Report: VEGA TECNOLOGIES DRIVE; NEBULIZER

Model Number	MQ5600
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, drive devilbiss healthcare was notified of an incident involving a nebulizer.The end user's daughter provided photographs of a small section of power cord that appeared to be burned.She reported that the cord "sparked and caught fire" several weeks ago when her father was using the device.Drive devilbiss healthcare is currently investigating the incident, including retrieving the product for inspection and evaluation.

• Brand Name: DRIVE
• Common Device Name: NEBULIZER
• Manufacturer (Section D): VEGA TECNOLOGIES; yangwu district; dalang town,; dongguan, guangdong 52378 9; CH 523789
• MDR Report Key: 14290376
• Report Number: 2438477-2022-00027
• Device Sequence Number: 5283333
• Product Code: CAF
• UDI-Device Identifier: 00689076349116
• UDI-Public: 689076349116
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/04/2022
• Report Date (Section F): 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MQ5600
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/08/2022
• Device Age: 66 MO
• Event Location: Home
• Date Report to Manufacturer: 05/04/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male
• Date Report Sent to FDA: 05/04/2022