FDA Adverse Event
Malfunction
Summary report: N
SECURE II MED/SURG BED
MDR report key: 2883831
·
Received November 15, 2012
Report
- Report Number
- 1831750-2012-11979
- Event Type
- Malfunction
- Date Received
- November 15, 2012
- Date of Event
- October 26, 2012
- Report Date
- October 26, 2012
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE BED BRAKES COULD BE ENGAGED ON EITHER SIDE BUT NOT DISENGAGED AS THE BRAKE PEDAL WAS SPONGY AND HAD DIFFICULTY RETURNING TO THE RELEASE POSITION IN THE RACE TRACK. THE CUSTOMER REPORTED THAT THEY DID NOT KNOW IF THERE WAS PT INVOLVEMENT OR IF THERE WERE 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 |