FDA Adverse Event
Malfunction
Summary report: N
M51P BLUE BASE W/MK5 NX SPJ+ 9153642087
MDR report key: 4813132
·
Received June 2, 2015
Report
- Report Number
- 1525712-2015-03206
- Event Type
- Malfunction
- Date Received
- June 2, 2015
- Report Date
- April 30, 2015
- Manufacturer
- INVACARE
- Product Code
- ITI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL RECORD WILL BE FILED.
Description of Event or Problem · 1
ENDUSER ADVISED END OF THE PLUG THAT GOES INTO THE BACK OF THE CHAIR TO CHARGE CHAIR CAME OFF, BATTERIES DO NOT HOLD A CHARGE. ENDUSER ADVISED STUCK OUTSIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 354215 | M51P BLUE BASE W/MK5 NX SPJ+ 9153642087 | WHEELCHAIR, POWERED | ITI | INVACARE | M51PSCTRSTR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |