FDA Adverse Event
Malfunction
Summary report: N
EPIC II
MDR report key: 3231132
·
Received July 12, 2013
Report
- Report Number
- 3231132
- Event Type
- Malfunction
- Date Received
- July 12, 2013
- Date of Event
- July 11, 2013
- Report Date
- July 12, 2013
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- RI, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
THE SIDE RAIL ON THE LEFT HAND SIDE APPEARS TO LOCK, BUT IF ANYONE LEANS ON IT, IT RELEASES WITHOUT WARNING.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 324647 | EPIC II | BED | FNL | STRYKER MEDICAL | 2040 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |