FDA Adverse Event
Malfunction
Summary report: N
NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE
MDR report key: 1965786
·
Received January 14, 2011
Report
- Report Number
- 1811755-2011-00133
- Event Type
- Malfunction
- Date Received
- January 14, 2011
- Date of Event
- December 16, 2010
- Report Date
- December 17, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- FYD
- PMA / PMN Number
- K012991
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A FIELD SERVICE TECH EVALUATED THE ROVER AND FOUND THAT POWER PLUG WAS PARTLY MELTED DUE TO ELECTRICAL CONNECTIONS BECOMING LOOSE. THE POWER PLUG WAS REPLACED AND THE ACCOUNT WAS TRAINED ON NOT PULLING THE PLUG OUT OF THE WALL BY THE CORD.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PLUG ON THE ROVER WAS PARTIALLY MELTED. THERE WAS NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES.
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 |