FDA Adverse Event
Malfunction
Summary report: N
NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE
MDR report key: 2003890
·
Received February 7, 2011
Report
- Report Number
- 1811755-2011-00364
- Event Type
- Malfunction
- Date Received
- February 7, 2011
- Date of Event
- August 6, 2010
- Report Date
- August 6, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- FYD
- PMA / PMN Number
- K012991
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE FIELD SVC REP FOUND THE POWER PLUG WAS MELTED FROM A LOOSE WIRE. THE PLUG WAS CHANGED AND THE UNIT WAS PUT BACK INTO SVC.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT NO POWER WAS GETTING TO THE ROVER. THE FIELD SVC REPAIR TECH REPORTED THAT THE POWER PLUG WAS MELTED FROM A LOOSE WIRE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE | AIR-HANDLING APPARATUS FOR A SURGICAL OPERATING RO | FYD | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |