FDA Adverse Event
Malfunction
Summary report: N
SECURE II MED/SURG BED
MDR report key: 2132308
·
Received June 13, 2011
Report
- Report Number
- 1831750-2011-05840
- Event Type
- Malfunction
- Date Received
- June 13, 2011
- Date of Event
- May 16, 2011
- Report Date
- May 16, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULT: MALFUNCTIONING FOWLER CLUTCH ASSEMBLY.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE FOWLER WAS DRIFTING DOWN WHEN RAISED TO AN ANGLE. IT IS UNK IF THERE WAS ANY PT INVOLVEMENT OR ADVERSE CONSEQUENCES TO REPORT.
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 |