FDA Adverse Event
Malfunction
Summary report: N
CUB PEDIATRIC CRIB- HYD BASE
MDR report key: 3102825
·
Received May 9, 2013
Report
- Report Number
- 0001831750-2013-04209
- Event Type
- Malfunction
- Date Received
- May 9, 2013
- Date of Event
- April 11, 2013
- Report Date
- April 11, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FMS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS MDR INITIAL REPORT IS A DUPLICATE OF A PREVIOUSLY ISSUED MDR. PLEASE SEE MDR # 1831750-2012-10039 FOR INFORMATION REGARDING THIS EVENT.
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE SCALE WEIGHT WAS NOT ACCURATE DUE TO THE LOAD CELLS AND THE SCALE BOARD. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE SCALE WEIGHT WAS NOT ACCURATE DUE TO THE LOAD CELLS AND THE SCALE BOARD. 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 |
|---|---|---|---|---|---|---|---|
| 203211 | CUB PEDIATRIC CRIB- HYD BASE | BED, PEDIATRIC OPEN HOSPITAL | FMS | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |