FDA Adverse Event
Malfunction
Summary report: N
SECURE II MED/SURG BED
MDR report key: 1991441
·
Received January 27, 2011
Report
- Report Number
- 1831750-2011-00871
- Event Type
- Malfunction
- Date Received
- January 27, 2011
- Date of Event
- January 4, 2011
- Report Date
- January 4, 2011
- Manufacturer
- STRYKER CORP., MEDICAL DIV.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: THE BED WAS ZEROED WITH A PT IN THE BED.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE BED EXIT ALARM IS NOT WORKING. IT IS UNK IF THERE WAS PT 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 |