FDA Adverse Event
Malfunction
Summary report: N
SECURE II MED/SURG BED
MDR report key: 2113465
·
Received May 25, 2011
Report
- Report Number
- 1831750-2011-05057
- Event Type
- Malfunction
- Date Received
- May 25, 2011
- Date of Event
- April 20, 2011
- Report Date
- April 27, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULTS: DAMAGED FOOT-END COVER DUE TO CONTACT WITH LIFT HEADER SCREWS. FOOT-END COVER SLICED COIL CABLE.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE BED HAD THE FOOT COVER DROPPING DUE TO LIFT PADS FALLING OFF OR SPLITTING. THE LOWERED FOOT COVER BANDED THE LIFT ASSEMBLY SCREW, DIMPLING THE COVER THEN SPLICING POWER CORD CABLE. THERE WAS NO PATIENT 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 |