MalfunctionCAF

DRIVE

Received Nov 1, 2024

Report 3003188183-2024-90004 · MDR key 20585208

Device

Generic name

Nebulizer

Manufacturer

Vega Technologies Inc.

Product problems

Thermal Decomposition of Device
Thermal Decomposition of Device

Patient

NA · Unknown

Insufficient Information
Insufficient Information

Narrative

Description of Event or Problem

VEGA FOUND THE MDR REPORT ON THE FDA WEBSITE AS ATTACHMENT 1 MDR NO. 2438477-2022-00027 MDR REPORT CONTENTS: ON (B)(6) 2022, DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A NEBULIZER. THE END USER'S DAUGHTER PROVIDED PHOTOGRAPHS OF ASMALL 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. NG Q'TY:(B)(4) PCS..