FDA Adverse Event
Malfunction
Summary report: N
CUB PEDIATRIC CRIB- HYD BASE
MDR report key: 4230318
·
Received November 6, 2014
Report
- Report Number
- 0001831750-2014-03321
- Event Type
- Malfunction
- Date Received
- November 6, 2014
- Date of Event
- October 16, 2014
- Report Date
- October 16, 2014
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FMS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE BRAKES CANNOT BE DISENGAGED AND THE SIDERAIL CANNOT BE LOCKED IN PLACE. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED. THIS ISSUE IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH IF IT WAS TO REOCCUR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 712710 | CUB PEDIATRIC CRIB- HYD BASE | PEDIATRIC OPEN HOSPITAL BED | FMS | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |