FDA Adverse Event
Malfunction
Summary report: N
NEPTUNE 2 DOCKING STATION (120V)
MDR report key: 2130040
·
Received May 5, 2011
Report
- Report Number
- 1811755-2011-01599
- Event Type
- Malfunction
- Date Received
- May 5, 2011
- Date of Event
- March 15, 2011
- Report Date
- March 15, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- FYD
- PMA / PMN Number
- K012991
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS EVALUATED BY A FIELD SERVICE TECHNICIAN AND THERE WERE NO LEAKS FOUND ON THE DOCKER. THERE WAS A WATER LEAK FOUND FROM THE BACK FLOW PREVENTER AND WATER HAMMER SYSTEM. THE CUSTOMER WAS INFORMED THAT THE ISSUE WAS A HOSPITAL PLUMBING ISSUE.
Description of Event or Problem · 1
IT WAS REPORTED THAT SOAPY WATER WAS LEAKING THROUGH TO THE FLOOR BELOW. THERE WAS NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEPTUNE 2 DOCKING STATION (120V) | FYD | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |