FDA Adverse Event
Malfunction
Summary report: N
SECURE 2 MED/SURGBED
MDR report key: 2061865
·
Received March 18, 2011
Report
- Report Number
- 1831750-2011-02586
- Event Type
- Malfunction
- Date Received
- March 18, 2011
- Date of Event
- February 18, 2011
- Report Date
- February 18, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULT CAUSE: BROKEN WELD.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT A FOWLER WELD WAS BROKEN, AND THE FOWLER COULD NOT GO INTO CPR POSITION, EITHER ELECTRICALLY OR MANUALLY. IT IS UNK 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 2 MED/SURGBED | A/C POWERED HOSPITAL BED | FNL | STRYKER MEDICAL | 3002 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |