MAUDE Adverse Event Report: VEGA TECNOLOGIES DRIVE; NEBULIZER

Model Number MQ5600

Device Problem Thermal Decomposition of Device (1071)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2021

Event Type  Injury  

Event 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
• Type of Device: NEBULIZER
• Manufacturer (Section D): VEGA TECNOLOGIES; yangwu district; dalang town,; dongguan, guangdong 52378 9; CH 523789
• MDR Report Key: 14290376
• MDR Text Key: 290903395
• Report Number: 2438477-2022-00027
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 00689076349116
• UDI-Public: 689076349116
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MQ5600
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/04/2022
• Distributor Facility Aware Date: 02/08/2022
• Device Age: 66 MO
• Event Location: Home
• Date Report to Manufacturer: 05/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Male