FDA Adverse Event
Malfunction
Summary report: N
SECURE II MED/SURG BED
MDR report key: 1874990
·
Received October 13, 2010
Report
- Report Number
- 1831750-2010-02827
- Event Type
- Malfunction
- Date Received
- October 13, 2010
- Date of Event
- September 16, 2010
- Report Date
- September 16, 2010
- Manufacturer
- STRYKER CORP. MEDICAL DIV.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULT: BED EXIT. THE CUSTOMER REPORTED THAT A NURSE WAS HAVING TROUBLE SETTING THE BED EXIT SYSTEM. THE FOOTBOARD WAS DISASSEMBLED BY CUSTOMER PRIOR TO FIELD TECH VISITING ACCOUNT. ONCE THE FOOTBOARD WAS PUT TOGETHER AGAIN BY THE FIELD TECH, HE REPORTED THE BED EXIT WORKED PROPERLY.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE BED EXIT WAS NOT WORKING. NO ADVERSE CONSEQUENCES HAVE BEEN 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 CORP. MEDICAL DIV. | 3002 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |