FDA Adverse Event
Malfunction
Summary report: N
3002 SECURE II
MDR report key: 2210223
·
Received July 11, 2011
Report
- Report Number
- 1831750-2011-06882
- Event Type
- Malfunction
- Date Received
- July 11, 2011
- Date of Event
- June 13, 2011
- Report Date
- June 13, 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: POWER CORD PLUG MISSING GROUND PRONG. 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 POWER CORD PLUG WAS MISSING THE GROUND PRONG. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.
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 |