FDA Adverse Event
Malfunction
Summary report: N
POWERED WHEELCHAIR
MDR report key: 3952077
·
Received July 23, 2014
Report
- Report Number
- 1525712-2014-03909
- Event Type
- Malfunction
- Date Received
- July 23, 2014
- Report Date
- June 17, 2014
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- ITI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
DEALER ADVISED RIGHT MOTOR AND GEARBOX CASING CAME LOOSE AND CAUSED GREASE TO LEAK OUT ON CARPET, DEALER ADVISED ENDUSER DID NOT REQUEST CARPET TO BE CLEANED, CHAIR WAS STILL FUNCTIONING, DEALER ADVISED CLEANED UP AND TIGHTENED SCREWS SO CLIENT CONTINUE TO USE CHAIR WHILE WAITING FOR REPAIR FROM ORDER (B)(4) NO INJURY, DEALER COULD NOT PROVIDE ANY FURTHER INFORMATION...(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 431989 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE TAYLOR STREET | TDXSP-MCG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |