MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-06-30 for * 4802 PEDIATRIC SCALE manufactured by Scale-tronix.
[2101245]
The scale could easily be turned from kilograms to pounds. The software was supposed to be locked to prevent access to pounds. Kilograms are the only measure of weight to be used in our pediatric hospital. There is an opportunity that staff does not realize that the scale went back to pounds and record the weight pounds. Medication doses are based on mg/kg (milligrams per kilograms).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2154234 |
| MDR Report Key | 2154234 |
| Date Received | 2011-06-30 |
| Date of Report | 2011-06-30 |
| Date of Event | 2011-06-24 |
| Report Date | 2011-06-30 |
| Date Reported to FDA | 2011-06-30 |
| Date Added to Maude | 2011-07-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | SCALE |
| Product Code | FRW |
| Date Received | 2011-06-30 |
| Model Number | 4802 PEDIATRIC SCALE |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SCALE-TRONIX |
| Manufacturer Address | 288 CARLTON DRIVE CAROL STREAM IL 60188 US 60188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-30 |