FDA Adverse Event
Malfunction
Summary report: N
EMAX 2 MOTOR
MDR report key: 3061443
·
Received April 10, 2013
Report
- Report Number
- 1045834-2013-01532
- Event Type
- Malfunction
- Date Received
- April 10, 2013
- Date of Event
- March 14, 2013
- Report Date
- March 15, 2013
- Manufacturer
- THE ANSPACH EFFORT, INC.
- Product Code
- HBC
- PMA / PMN Number
- K080802
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RECEIVED BY ANSPACH. IF ADD'L INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).
Description of Event or Problem · 1
REPORT RECEIVED FROM THE USA STATING THAT DURING THE PRE-TEST THE DEVICE WAS "GETTING HOT." THE DEVICE WAS NOT USED IN SURGERY. THERE WERE NO INJURIES OR MEDICAL INTERVENTION REPORTED. THERE WAS NO ADD'L INFO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 153401 | EMAX 2 MOTOR | HBC | THE ANSPACH EFFORT, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |