MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2011-08-12 for PEDIATRIC SCALE 4802 manufactured by Scale-tronix, Inc..
[20217750]
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 the user's pediatric hospital. There was an opportunity that staff does not realize that the scale went back to pounds and record the weight ponds. Medication doses are based on mg/kg (milligrams per kilograms).
Patient Sequence No: 1, Text Type: D, B5
[20592448]
Scales are normally configured to toggle between pounds and kilograms. Customer can request scale to be programmed at factory to kilograms only or it can be accomplished on-site using the instructions in the operation manual beginning on page 4. In this situation the scales (sns (b)(4)) were ordered from the hosp as a normally configured pediatric scale with pounds and kilograms active.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419590-2011-00001 |
| MDR Report Key | 2335177 |
| Report Source | 99 |
| Date Received | 2011-08-12 |
| Date of Report | 2011-08-12 |
| Date of Event | 2011-06-01 |
| Date Mfgr Received | 2011-07-11 |
| Device Manufacturer Date | 2010-10-01 |
| Date Added to Maude | 2012-06-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 288 CARLTON DR |
| Manufacturer City | CAROL STREAM IL 60188 |
| Manufacturer Country | US |
| Manufacturer Postal | 60188 |
| Manufacturer Phone | 6306353377 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PEDIATRIC SCALE |
| Generic Name | SCALE |
| Product Code | FRW |
| Date Received | 2011-08-12 |
| Model Number | 4802 |
| Lot Number | UNK |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SCALE-TRONIX, INC. |
| Manufacturer Address | 288 CARLTON CAROL STREAM IL 60188 US 60188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-12 |