FDA Adverse Event
Malfunction
Summary report: N
SECURE II MED/SURG BED
MDR report key: 1963945
·
Received January 12, 2011
Report
- Report Number
- 1831750-2011-00390
- Event Type
- Malfunction
- Date Received
- January 12, 2011
- Date of Event
- December 15, 2010
- Report Date
- December 15, 2010
- Manufacturer
- STRYKER CORP., MEDICAL DIV.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULT: SIDERAIL, SIDERAIL PANELS, SIDERAIL WELDMENTS.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE PATIENT LEFT AND RIGHT FOOT SIDERAILS HAVE BEEN BROKEN AND WILL NOT LATCH IN THE UP POSITION. IT WAS FURTHER REPORTED THE SIDERAIL WELDMENTS WERE BROKEN AND THERE WERE SHARP EDGES, AND THAT THE SIDERAIL PANELS WERE DAMAGED. 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 CORP., MEDICAL DIV. | 3002 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |