FDA Adverse Event
Malfunction
Summary report: N
SECURE 2 MED/SURG BED
MDR report key: 2033357
·
Received March 22, 2011
Report
- Report Number
- 1831750-2011-02646
- Event Type
- Malfunction
- Date Received
- March 22, 2011
- Date of Event
- February 23, 2011
- Report Date
- February 23, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULT: THE WRONG LABEL HAD BEEN PUT ON THE MODULE BUTTONS BY SOMEONE OTHER THAN A STRYKER EMPLOYEE AND THE GRAPHICS ON IT DID NOT LINE UP WITH THE MODULE BUTTONS UNDERNEATH.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE SCALE WAS NOT FUNCTIONING PROPERLY, AND THE POWER CORD'S GROUND PRONG WAS LOOSE. 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/SURG BED | A/C POWERED HOSPITAL BED | FNL | STRYKER MEDICAL | 3002 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |