FDA Adverse Event
Malfunction
Summary report: N
SECURE II MED/SURG BED
MDR report key: 1982307
·
Received January 13, 2011
Report
- Report Number
- 1831750-2011-00467
- Event Type
- Malfunction
- Date Received
- January 13, 2011
- Date of Event
- December 16, 2010
- Report Date
- December 16, 2010
- Manufacturer
- STRYKER CORP., MEDICAL DIV.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULT: MISSING SIDERAIL MODULE; COMMUNICATION CORD; SIDERAIL PANEL. THIS USER FACILITY SERVES AS THE HEALTH CARE PROVIDER FOR ONE OF THE STATE PRISONS. AS A RESULT, IT HAS BEEN REPORTED THAT PATIENTS INTENTIONALLY DAMAGE VARIOUS DEVICE COMPONENTS WITH UNRESTRAINED APPENDAGES. ADDITIONALLY, PATIENTS 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 INNER LEFT SIDERAIL PANEL WAS MISSING THE BLANK MODULE. IT WAS FURTHER REPORTED THE BED'S COMM CORD HAD BENT PINS AND THE HEAD RIGHT OUTER SIDERAIL PANEL WAS CRACKED RESULTING IN SHARP EDGES. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT OR IF THERE ARE ADVERSE CONSEQUENCES TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SECURE II MED/SURG BED | AC POWERED HOSPITAL BED | FNL | STRYKER CORP., MEDICAL DIV. | 3002 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |