FDA Adverse Event
Malfunction
Summary report: N
SECURE II MED/SURG BED
MDR report key: 2051355
·
Received April 4, 2011
Report
- Report Number
- 1831750-2011-03217
- Event Type
- Malfunction
- Date Received
- April 4, 2011
- Date of Event
- March 10, 2011
- Report Date
- March 10, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULT: MALFUNCTIONING POTENTIOMETER DUE TO LOSE LIFT GEAR CASE BOLTS ON FOOT-END AND HEAD-END.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE BED GOES INTO TREND WHEN IT IS RAISED UP NORMALLY. IT IS UNK IF THERE WAS PT INVOLVEMENT, HOWEVER, NO ADVERSE CONSEQUENCES WERE 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 MEDICAL | 3002 EX | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |