FDA Adverse Event
Malfunction
Summary report: N
3002 SECURE II
MDR report key: 2232833
·
Received July 19, 2011
Report
- Report Number
- 1831750-2011-07233
- Event Type
- Malfunction
- Date Received
- July 19, 2011
- Date of Event
- June 20, 2011
- Report Date
- June 20, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULT: MISSING FOOTBOARD MODULES. DAMAGED FOOTBOARD HINGE PLATE. THIS USER FACILITY SERVES AS THE HEALTH CARE PROVIDER FOR ONE OF THE STATE PRISONS. AS A RESULT, IT HAS BEEN REPORTED THAT PTS INTENTIONALLY DAMAGE VARIOUS DEVICE COMPONENTS WITH UNRESTRAINED APPENDAGES. ADDITIONALLY, PTS ARE REGULARLY RESTRAINED IN MANNERS THAT CONFLICT WITH THE DEVICE'S INSTRUCTIONS FOR USE.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE FOOTBOARD WAS BROKEN, WITH MISSING THE END AND A BLANK MODULE, AND THE HINGE PLATE WAS DAMAGED. IT IS UNK IF THERE WAS PT INVOLVEMENT OR ADVERSE CONSEQUENCES TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3002 SECURE II | A/C POWERED HOSPITAL BED | FNL | STRYKER MEDICAL | 3002 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |