MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-11-09 for DETECTO SCALE 6745 62450-300 manufactured by Cardinal Health.
[1672982]
Baby scale readings inaccurate by 5-10% wt differences. Biomed has calibrated and attempted to remedy the issue, and when the scale reads their test using a 10 pound weight it reads accurately, but when weighing a moving infant the weights are consistently off by 5-10% of the actual weight. ====================== health professional's impression======================scale does not read accurately and consistently especially with infant moving intermittently.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1901739 |
| MDR Report Key | 1901739 |
| Date Received | 2010-11-09 |
| Date of Report | 2010-11-09 |
| Date of Event | 2010-11-07 |
| Report Date | 2010-11-09 |
| Date Reported to FDA | 2010-11-09 |
| Date Added to Maude | 2010-11-17 |
| 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 | DETECTO SCALE |
| Generic Name | SCALE, INFANT |
| Product Code | FRW |
| Date Received | 2010-11-09 |
| Model Number | 6745 |
| Catalog Number | 62450-300 |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | 203 EAST DAUGHERTY WEBB CITY MO 64870 US 64870 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-11-09 |