FDA Adverse Event
Malfunction
Summary report: N
BLACKMAX SYSTEM MOTOR
MDR report key: 514191
·
Received January 22, 2004
Report
- Report Number
- 1045834-2004-00054
- Event Type
- Malfunction
- Date Received
- January 22, 2004
- Date of Event
- December 12, 2003
- Report Date
- January 19, 2004
- Manufacturer
- THE ANSPACH EFFORT, INC.
- Product Code
- HBB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CUSTOMER STATED MOTOR SEEMED TO RUN INTERMITTENTLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BLACKMAX SYSTEM MOTOR | MOTOR | HBB | THE ANSPACH EFFORT, INC. | BLACKMAX-N | A65124A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |