FDA Adverse Event
Malfunction
Summary report: N
DRIVE
MDR report key: 16273308
·
Received January 31, 2023
Report
- Report Number
- 2438477-2023-00001
- Event Type
- Malfunction
- Date Received
- January 31, 2023
- Date of Event
- December 23, 2022
- Report Date
- January 30, 2023
- Manufacturer
- GUANGDONG PRESTIGE TECHNOLOGY CO., LTD.
- Product Code
- INI
- UDI-DI
- 00822383927350
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A POWER SCOOTER BY AN END USER, WHO STATED THAT "HIS SCOOTER WAS ON HIS FRONT PORCH AND CAUGHT FIRE ONE AFTERNOON. THE FIRE DEPARTMENT HAD TO COME AND PUT THE FIRE OUT." THE END USER ALSO STATED THAT "THE SCOOTER WAS NOT CHARGING OR PLUGGED INTO AN OUTLET." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. THERE WAS NO INFORMATION REGARDING WHETHER THE END USER WAS STORING HIS SCOOTER OUTDOORS ON A REGULAR BASIS. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 897023 | DRIVE | POWER SCOOTER | INI | GUANGDONG PRESTIGE TECHNOLOGY CO., LTD. | FLEX-AUTO | 00822383927350 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Male |