FDA Adverse Event
Malfunction
Summary report: N
SYSTEM CONSOLE
MDR report key: 3043036
·
Received March 7, 2013
Report
- Report Number
- 1045834-2013-00579
- Event Type
- Malfunction
- Date Received
- March 7, 2013
- Date of Event
- January 27, 2011
- Report Date
- January 27, 2011
- 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 WAS 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 THE ¿CONSOLE FAN SEEMS TO TURN ON IMMEDIATELY¿. THE DEVICE WAS BEING USED DURING A PROCEDURE. NO PATIENT OR USER INJURIES WERE REPORTED. THERE WAS NO ADD¿L INFO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 98375 | SYSTEM CONSOLE | HBC | THE ANSPACH EFFORT, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |