FDA Adverse Event
Malfunction
Summary report: N
CUB PEDIATRIC CRIB- HYD BASE
MDR report key: 3231251
·
Received July 17, 2013
Report
- Report Number
- 0001831750-2013-06419
- Event Type
- Malfunction
- Date Received
- July 17, 2013
- Date of Event
- June 20, 2013
- Report Date
- June 20, 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 DROPS QUICKLY WHILE LOWERING DUE TO BROKEN ASSIST CABLE. 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 |
|---|---|---|---|---|---|---|---|
| 332530 | CUB PEDIATRIC CRIB- HYD BASE | BED, PEDIATRIC OPEN HOSPITAL | FMS | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |