FDA Adverse Event
Malfunction
Summary report: N
NEPTUNE ROVER WITHOUT SMOKE EVAC AND POWER POLE
MDR report key: 2051547
·
Received February 25, 2011
Report
- Report Number
- 1811755-2011-00581
- Event Type
- Malfunction
- Date Received
- February 25, 2011
- Date of Event
- January 26, 2011
- Report Date
- January 26, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- FYD
- PMA / PMN Number
- K012991
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE ROVER'S POWER CORD WAS REPLACED. THE DEVICE PASSED ALL TESTING AND WAS RETURNED TO SERVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE EXAMINING THE POWER PLUG ON THE ROVER, THE FIELD SERVICE REPRESENTATIVE SAW AN ARC OF ELECTRICITY IN THE PLUG CASING. THERE WAS NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEPTUNE ROVER WITHOUT 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 |