FDA Adverse Event
Malfunction
Summary report: N
NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE
MDR report key: 1970400
·
Received January 18, 2011
Report
- Report Number
- 1811755-2011-00153
- Event Type
- Malfunction
- Date Received
- January 18, 2011
- Date of Event
- December 17, 2010
- Report Date
- December 20, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- FYD
- PMA / PMN Number
- K012991
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE FIELD SERVICE TECHNICIAN EVALUATED THE PLUG AND REMOVED THE COVER AND FOUND THAT THE BROWN WIRE WAS MELTED. IT APPEARED THAT THE USER WAS PULLING THE PLUG FROM THE WIRE TO REMOVE IT FROM THE WALL. THERE WAS A LOT OF WIRE SHOWING AT THE PLUG END. THE WIRES WERE REPAIRED AND THE PLUG WAS REPAIRED. THE DEVICE WAS PASSED ALL TESTS AND WAS RETURNED TO SERVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A SERVICE REPAIR VISIT, THE FIELD SERVICE TECH FOUND THAT THE POWER PLUG HAD A MELTED BROWN WIRE.
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 | 0700001000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |