FDA Adverse Event
Malfunction
Summary report: N
NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE
MDR report key: 2003876
·
Received February 7, 2011
Report
- Report Number
- 1811755-2011-00361
- Event Type
- Malfunction
- Date Received
- February 7, 2011
- Date of Event
- July 14, 2010
- Report Date
- July 15, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- FYD
- PMA / PMN Number
- K012991
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE FIELD SVC TECH REPORTED THAT THE PLUG HAD SIGNS OF SHORTING OUT AND MELTING PLASTIC. THE PLUG WAS REPLACED AND IT PASSED ALL FUNCTIONAL TESTS. THE UNIT WAS RETURNED TO SVC.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE EVALUATING THE DEVICE ON A SVC VISIT THE FIELD SVC TECH FOUND THAT THE POWER PLUG WAS MELTED. THERE WERE NO FLAMES OR SMOKE REPORTED WITH THIS EVENT AND THERE WERE NO 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 |