FDA Adverse Event
Malfunction
Summary report: N
SECURE II MED/SURG BED
MDR report key: 3023114
·
Received March 27, 2013
Report
- Report Number
- 0001831750-2013-02577
- Event Type
- Malfunction
- Date Received
- March 27, 2013
- Date of Event
- March 4, 2013
- Report Date
- March 4, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY REPAIR WORK ORDER THAT THE SIDERAIL CONTROLS WERE NOT FUNCTIONING DUE TO DAMAGED SIDERAIL CABLES. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCES OR CLINICALLY RELEVANT DELAYS IN TREATMENT WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 125761 | SECURE II MED/SURG BED | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |