FDA Adverse Event
Malfunction
Summary report: N
SECURE II MED/SURG BED
MDR report key: 3162254
·
Received June 11, 2013
Report
- Report Number
- 0001831750-2013-05270
- Event Type
- Malfunction
- Date Received
- June 11, 2013
- Date of Event
- May 17, 2013
- Report Date
- May 17, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THERE WAS REDUCED BRAKE FORCE DUE TO A WORN SCORPION BRAKE KIT. IT WAS ALSO REPORTED THAT THE BRAKES WOULD NOT ENGAGE DUE TO BASE ASSEMBLY MALFUNCTION. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 263031 | SECURE II MED/SURG BED | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |