FDA Adverse Event
Malfunction
Summary report: N
SECURE II MED/SURG BED
MDR report key: 2081778
·
Received April 13, 2011
Report
- Report Number
- 1831750-2011-03505
- 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
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULT: WRONG FOOTBOARD WAS INSTALLED TO THE BED.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE BED EXIT MODULE WAS BLINKING AND WOULD NOT SET. IT IS UNK IF THERE WAS PT INVOLVEMENT. HOWEVER, NO 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 |