FDA Adverse Event
Malfunction
Summary report: N
CUB PEDIATRIC CRIB- HYD BASE
MDR report key: 3915641
·
Received July 7, 2014
Report
- Report Number
- 0001831750-2014-03133
- Event Type
- Malfunction
- Date Received
- July 7, 2014
- Date of Event
- June 11, 2014
- Report Date
- June 11, 2014
- 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 BY SERVICE REPORT THAT THE SCALE IS INACCURATE DUE TO DAMAGED LOAD CELLS. 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 |
|---|---|---|---|---|---|---|---|
| 393841 | CUB PEDIATRIC CRIB- HYD BASE | BED, PEDIATRIC OPEN HOSPITAL | FMS | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |