FDA Adverse Event
Malfunction
Summary report: N
SECURE ACUTE CARE BED
MDR report key: 2920445
·
Received December 7, 2012
Report
- Report Number
- 1831750-2012-12486
- Event Type
- Malfunction
- Date Received
- December 7, 2012
- Date of Event
- November 13, 2012
- Report Date
- November 13, 2012
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE INNER/OUTER BUTTONS DID NOT OPERATE ON EITHER SIDE RAIL. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SECURE ACUTE CARE BED | A/C POWERED HOSPITAL BED | FNL | STRYKER MEDICAL | 3000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |