FDA Adverse Event
Malfunction
Summary report: N
TDXSP ELECTRIC RED EURO WIDE BASE W/ 23-1 SSD GEAR BOX
MDR report key: 4913019
·
Received July 14, 2015
Report
- Report Number
- 1525712-2015-03855
- Event Type
- Malfunction
- Date Received
- July 14, 2015
- Report Date
- July 17, 2015
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- ITI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS EVALUATED BY THE RETURNS DEPARTMENT WHICH FOUND THAT THE STANDOFF IS BROKEN AND ALLOWING FOR A LOOSE CONNECTION DURING BENCH TEST.
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL RECORD WILL BE FILED.
Description of Event or Problem · 1
THE DEALER STATES A PART IS BROKEN OFF OF HE MOTOR. THE DEALER STATES THAT IT IS A NUT THAT IS FUSED TO THE CONNECTOR. THE DEALER STATES WHEN THE PATIENT HITS A BUMP IT WOULD CAUSE THE MOTOR TO CUT OUT.
Description of Event or Problem · 1
THE DEALER STATES A PART IS BROKEN OFF OF HE MOTOR. THE DEALER STATES THAT IT IS A NUT THAT IS FUSED TO THE CONNECTOR. THE DEALER STATES WHEN THE PATIENT HITS A BUMP IT WOULD CAUSE THE MOTOR TO CUT OUT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 455868 | TDXSP ELECTRIC RED EURO WIDE BASE W/ 23-1 SSD GEAR BOX | WHEELCHAIR, POWERED | ITI | INVACARE TAYLOR STREET | TDXSR-CG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |