FDA Adverse Event
Malfunction
Summary report: N
CUB PEDIATRIC CRIB- HYD BASE
MDR report key: 2112286
·
Received April 29, 2011
Report
- Report Number
- 1831750-2011-04170
- Event Type
- Malfunction
- Date Received
- April 29, 2011
- Date of Event
- April 4, 2011
- Report Date
- April 4, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FMS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
SCALE OUT OF CALIBRATION.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE SCALE NEEDS TO BE CALIBRATED. IT IS UNK IF THERE WAS PT INVOLVEMENT, HOWEVER NO ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CUB PEDIATRIC CRIB- HYD BASE | BED, PEDIATRIC OPEN HOSPITAL | FMS | STRYKER MEDICAL | FL19H | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |