FDA Adverse Event
Malfunction
Summary report: N
PRONTO M61
MDR report key: 4333525
·
Received December 16, 2014
Report
- Report Number
- 1525712-2014-07985
- Event Type
- Malfunction
- Date Received
- December 16, 2014
- Date of Event
- September 24, 2014
- Report Date
- October 27, 2014
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- ITI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
ENDUSER ADVISED CHAIR WILL GO A LITTLE BIT AND THEN STOPPED. ENDUSER ADVISED SOMEONE CAME OUT TO LOOK AT CHAIR AND ADVISED NEED BATTERIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 825217 | PRONTO M61 | WHEELCHAIR, POWERED | ITI | INVACARE TAYLOR STREET | M71 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |