FDA Adverse Event
Malfunction
Summary report: N
EMAX 2 PLUS MOTOR
MDR report key: 3042640
·
Received April 2, 2013
Report
- Report Number
- 1045834-2013-01147
- Event Type
- Malfunction
- Date Received
- April 2, 2013
- Report Date
- August 9, 2011
- Manufacturer
- THE ANSPACH EFFORT, INC.
- Product Code
- HBC
- PMA / PMN Number
- K080802
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED BY ANSPACH. IF ADDITIONAL INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.
Description of Event or Problem · 1
THE REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE "OVERHEATED SEVERAL TIMES". THE DEVICE WAS BEING USED DURING KNEE SURGERY. THERE WAS NO REPORTED PT OR USER INJURIES. THE DATE OF THE EVENT IS UNK. THERE WAS NO ADDITIONAL INFO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 134472 | EMAX 2 PLUS MOTOR | HBC | THE ANSPACH EFFORT, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |