FDA Adverse Event
Malfunction
Summary report: N
CUB PEDIATRIC CRIB- FIXED BASE
MDR report key: 3870132
·
Received June 12, 2014
Report
- Report Number
- 0001831750-2014-03064
- Event Type
- Malfunction
- Date Received
- June 12, 2014
- Date of Event
- May 16, 2014
- Report Date
- May 19, 2014
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FMS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE SIDERAIL WILL NOT LOCK IN PLACE DUE TO BROKEN COMPONENTS. 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 |
|---|---|---|---|---|---|---|---|
| 348372 | CUB PEDIATRIC CRIB- FIXED BASE | BED, PEDIATRIC OPEN HOSPITAL | FMS | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |