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

Model Number 18081

Device Problem Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/13/2022

Event Type  malfunction  

Event 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
• Type of Device: NEBULIZER
• Manufacturer (Section D): VEGA TECHNOLOGIES INC.; yangwu district; dalang town; dongguan, guangdong 52378 9; CH 523789
• MDR Report Key: 15419206
• MDR Text Key: 299871693
• Report Number: 2438477-2022-00069
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 00822383504131
• UDI-Public: 00822383504131
• 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: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 18081
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/14/2022
• Event Location: Home
• Date Report to Manufacturer: 09/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1