FDA Adverse Event
Malfunction
Summary report: N
TDXSP ELECTRIC RED EURO WIDE BASE W/ 23-1 SSD GEAR BOX
MDR report key: 4897898
·
Received July 8, 2015
Report
- Report Number
- 1525712-2015-03788
- Event Type
- Malfunction
- Date Received
- July 8, 2015
- Report Date
- July 13, 2015
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- ITI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL RECORD WILL BE FILED.
Additional Manufacturer Narrative · 1
(B)(4). PER RETURN EVALUATION RECEIVED (B)(4) 2015: BRAKE WILL NOT ELECTRICALLY ENGAGE DURING BENCH TEST BUT NO FAULT CODE ON THE JOYSTICK.
Description of Event or Problem · 1
PROVIDER STATES THAT THE USER GOES DOWN HIS RAMP AND WHEN HE LETS GO OF THE JOYSTICK THE CHAIR GOES INTO CIRCLES, THE BRAKE IS STAYING OPEN ON THE RIGHT MOTOR.
Description of Event or Problem · 1
PROVIDER STATES THAT THE USER GOES DOWN HIS RAMP AND WHEN HE LETS GO OF THE JOYSTICK THE CHAIR GOES INTO CIRCLES, THE BRAKE IS STAYING OPEN ON THE RIGHT MOTOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 441768 | TDXSP ELECTRIC RED EURO WIDE BASE W/ 23-1 SSD GEAR BOX | WHEELCHAIR, POWERED | ITI | INVACARE TAYLOR STREET | TDXSP-MCG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |