FDA Adverse Event
Malfunction
Summary report: N
DRIVE
MDR report key: 17086552
·
Received June 8, 2023
Report
- Report Number
- 2438477-2023-00055
- Event Type
- Malfunction
- Date Received
- June 8, 2023
- Report Date
- June 8, 2023
- Manufacturer
- WU'S TECH CO., LTD.
- Product Code
- ITI
- UDI-DI
- 00822383579559
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF A COMPLAINT REGARDING A MOTORIZED SCOOTER'S BATTERY CHARGER BY AN END USER, WHO STATED THAT HE "HE PLUGGED THE CHARGER INTO THE WALL CONNECTED TO THE SCOOTER, AND AN ELECTRICAL FIRE STARTED." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. THE END USER ALSO CONFIRMED THAT THERE WAS NO PROPERTY DAMAGE ASSOCIATED WITH THE INCIDENT. HE DID NOT PROVIDE ANY INFORMATION REGARDING THE OUTLET INVOLVED IN THE INCIDENT. DRIVE WILL NOT BE ABLE TO PERFORM A PRODUCT EVALUATION, AS THE END USER CONFIRMED THAT HE DISPOSED OF THE CHARGER FOLLOWING THE INCIDENT. DRIVE WILL CONTINUE TO MONITOR COMPLAINTS FOR ANY RELATED TRENDS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1428025 | DRIVE | POWERED WHEELCHAIR | ITI | WU'S TECH CO., LTD. | PHOENIXHD4-20 | 00822383579559 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male |