FDA Adverse Event
Malfunction
Summary report: N
DRIVE
MDR report key: 20585208
·
Received November 1, 2024
Report
- Report Number
- 3003188183-2024-90004
- Event Type
- Malfunction
- Date Received
- November 1, 2024
- Manufacturer
- VEGA TECHNOLOGIES INC.
- Product Code
- CAF
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
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..
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1930020 | DRIVE | NEBULIZER | CAF | VEGA TECHNOLOGIES INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |