FDA Adverse Event
Malfunction
Summary report: N
NEPTUNE 2 DOCKING STATION (120V)
MDR report key: 3131785
·
Received May 29, 2013
Report
- Report Number
- 0001811755-2013-01229
- Event Type
- Malfunction
- Date Received
- May 29, 2013
- Date of Event
- May 3, 2013
- Report Date
- May 3, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- FYD
- PMA / PMN Number
- K012991
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN REPLACED THE POWER PLUG AND RETURNED THE UNIT TO SERVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A FIELD SERVICE MAINTENANCE VISIT IT WAS NOTED THAT THE POWER PLUG WAS SPARKING. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 235526 | NEPTUNE 2 DOCKING STATION (120V) | APPARATUS, EXHAUST, SURGICAL | FYD | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |