FDA Adverse Event
Malfunction
Summary report: N
SECURE II MED/SURG BED
MDR report key: 3052814
·
Received April 11, 2013
Report
- Report Number
- 0001831750-2013-03176
- Event Type
- Malfunction
- Date Received
- April 11, 2013
- Date of Event
- March 20, 2013
- Report Date
- March 20, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUPPLEMENTAL SUBMITTED AS INVESTIGATION CONCLUDED THIS EVENT WAS PREVIOUSLY REPORTED IN MEDWATCH 0001831750-2013-03297.
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE POWER CORD WAS MISSING THE GROUND PIN. ADDITIONALLY THE LEFT AND RIGHT SIDERAILS HAD BROKEN CABLES. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE POWER CORD WAS MISSING THE GROUND PIN. ADDITIONALLY THE LEFT AND RIGHT SIDERAILS HAD BROKEN CABLES. 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 |
|---|---|---|---|---|---|---|---|
| 155072 | SECURE II MED/SURG BED | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |