FDA Adverse Event
Malfunction
Summary report: N
POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI
MDR report key: 4941819
·
Received July 27, 2015
Report
- Report Number
- 1525712-2015-04016
- Event Type
- Malfunction
- Date Received
- July 27, 2015
- Report Date
- August 5, 2015
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- ITI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, 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
THE DEVICE WAS EVALUATED BY THE RETURNS DEPARTMENT WHICH FOUND THAT THE MOTOR IS UNABLE TO BE TESTED UNDER LOAD. IT WAS FOUND FOR THE MOTOR TO HAVE BROKEN STRAIN RELIEF AND CUT WIRE, VISUAL DAMAGE TO THE SHIPPING BOX. THE GEARBOX HAD NO VISUAL EVIDENCE OF GREASE LEAK. PASSED SCIEMETRICS. GOOD COUPLER.
Description of Event or Problem · 1
THE PROVIDER STATES THE CHAIR HAD A 700 FAULT CODE AND THE CHAIR VEERED TO THE LEFT ALMOST HITTING A PERSON WHILE ON A SIDEWALK.
Description of Event or Problem · 1
THE PROVIDER STATES THE CHAIR HAD A 700 FAULT CODE AND THE CHAIR VEERED TO THE LEFT ALMOST HITTING A PERSON WHILE ON A SIDEWALK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 485813 | POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI | WHEELCHAIR, POWERED | ITI | INVACARE TAYLOR STREET | TDXSP-CG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |