FDA Adverse Event
Malfunction
Summary report: N
XPRT SLEEP SURFACE
MDR report key: 2111364
·
Received May 18, 2011
Report
- Report Number
- 1313850-2011-00113
- Event Type
- Malfunction
- Date Received
- May 18, 2011
- Date of Event
- April 20, 2011
- Report Date
- April 20, 2011
- Manufacturer
- STRYKER CORP DBA GAYMAR
- Product Code
- FNM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
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 HAD BEEN CUT, RESULTING IN EXPOSED WIRES. IT IS UNK IF THERE WAS PT INVOLVEMENT OR IF THERE WERE ADVERSE CONSEQUENCES TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XPRT SLEEP SURFACE | MATTRESS | FNM | STRYKER CORP DBA GAYMAR | 2950 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |