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