FDA Adverse Event
Malfunction
Summary report: N
SECURE II MED/SURG BED
MDR report key: 3092230
·
Received May 3, 2013
Report
- Report Number
- 0001831750-2013-04063
- Event Type
- Malfunction
- Date Received
- May 3, 2013
- Date of Event
- April 12, 2013
- Report Date
- April 12, 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 POWER CORD HAD A BROKEN POWER PRONG. IT WAS ALSO REPORTED THAT THE POWER CORD HAD A MISSING GROUND PRONG. IT WAS FURTHER REPORTED THAT THE MOTION INTERRUPT PAN WAS BROKEN. 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 |
|---|---|---|---|---|---|---|---|
| 193996 | SECURE II MED/SURG BED | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |