FDA Adverse Event
Malfunction
Summary report: N
SECURE II MED/SURG BED
MDR report key: 2081766
·
Received April 13, 2011
Report
- Report Number
- 1831750-2011-03459
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Date of Event
- March 21, 2011
- Report Date
- March 21, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULTS: MAIN AND AUXILIARY POWER CORDS PLUGS GROUND PINS WERE MISSING. BROKEN FOOTBOARD LID.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE POWER AND AUXILIARY POWER CORDS GROUND PRONGS WERE MISSING. IT WAS FURTHER REPORTED THAT THE FOOTBOARD LID WAS BROKEN RESULTING IN EXPOSED SHARP EDGES. NO PATIENT INVOLVEMENT OR 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 |