FDA Adverse Event
Malfunction
Summary report: N
SECURE II MED/SURG BED
MDR report key: 3113488
·
Received May 15, 2013
Report
- Report Number
- 0001831750-2013-04409
- Event Type
- Malfunction
- Date Received
- May 15, 2013
- Date of Event
- April 19, 2013
- Report Date
- April 22, 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 THE SCALE WAS INACCURATE DUE TO CALIBRATION AND IT WAS ALSO REPORTED THAT MOTION INTERRUPT PAN WAS DAMAGED. 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 |
|---|---|---|---|---|---|---|---|
| 214193 | SECURE II MED/SURG BED | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |