FDA Adverse Event
Malfunction
Summary report: N
RASCAL
MDR report key: 2102305
·
Received May 16, 2011
Report
- Report Number
- 2246975-2011-00004
- Event Type
- Malfunction
- Date Received
- May 16, 2011
- Date of Event
- May 20, 2010
- Report Date
- May 18, 2011
- Manufacturer
- ELECTRIC MOBILITY CORP.
- Product Code
- INI
- Removal / Correction Number
- Z-0174/0175-2008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ELECTRIC MOBILITY CORPORATION FAILED TO REPORT THIS MALFUNCTION WITHIN 30 DAYS.
Description of Event or Problem · 1
ON (B)(6) 2010 - SERVICE CENTER WENT TO CUSTOMER'S LOCATION TO REPAIR THE SEAT LIFT AS PART OF RECALL Z-0174/0175-2008. THE SERVICE CENTER INFORMED ELECTRIC MOBILITY THAT, WHILE PERFORMING THE REPAIR, THE SEAT LIFT MASTER BOLTS BROKE. ON (B)(6) 2010 - SERVICE CENTER RECEIVED NEW SEAT LIFT AND COMPLETED THE REPAIR. ON (B)(6) 2010 - RETURN AUTHORIZATION RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RASCAL | VEHICLE, 3 WHEELED, MOTORIZED | INI | ELECTRIC MOBILITY CORP. | 600T |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |