FDA Adverse Event
Malfunction
Summary report: N
CUB PEDIATRIC CRIB- HYD BASE
MDR report key: 3073412
·
Received April 23, 2013
Report
- Report Number
- 0001831750-2013-03688
- Event Type
- Malfunction
- Date Received
- April 23, 2013
- Date of Event
- March 28, 2013
- Report Date
- March 28, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FMS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE SIDE RAIL COULD DROP DUE TO BROKEN ASSIST CABLE AND DAMAGED ASSIST PULLEY. 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 |
|---|---|---|---|---|---|---|---|
| 175618 | CUB PEDIATRIC CRIB- HYD BASE | BED, PEDIATRIC OPEN HOSPITAL | FMS | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |