FDA Adverse Event
Malfunction
Summary report: N
SECURE II MED/SURG BED
MDR report key: 2000268
·
Received February 3, 2011
Report
- Report Number
- 1831750-2011-01059
- Event Type
- Malfunction
- Date Received
- February 3, 2011
- Date of Event
- January 25, 2011
- Report Date
- January 25, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULT: GLIDE RODS, TIMING LINK.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE HEAD LEFT SIDE RAIL WAS STUCK IN THE DOWN STOW AWAY POSITION AND COULD NOT BE RAISED OR LOCKED AND THAT ITS PANELS WERE DAMAGED. IT WAS FURTHER REPORTED THAT THE HEAD RIGHT SIDERAIL COULD NOT BE LOCKED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT, HOWEVER NO ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SECURE II MED/SURG BED | A/C POWERED HOSPITAL BED | FNL | STRYKER MEDICAL | 3002 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |