MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-06-19 for ADULT AND INFANT SCALE 1582 manufactured by Tanita Corp Of America.
[26686]
The main problem is understanding what the scale is reading when it is in use in the infant mode. The scale had two modes, one for infants, and the other one for adults. It also gives you two choices, pounds and kilograms. When it is used in pounds, the display reads 0. 00 pounds. When it is in pounds/ounces, if for example it reads 10. 13, it does not mean 10 pounds and. 13 decimals, it means 10 pounds, and. 13 ounces. "we were confused and decide to send the scale was fine. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1009312 |
| MDR Report Key | 33516 |
| Date Received | 1996-06-19 |
| Date of Report | 1996-06-18 |
| Date of Event | 1996-06-01 |
| Date Added to Maude | 1996-06-21 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADULT AND INFANT SCALE |
| Generic Name | SCALE |
| Product Code | FRI |
| Date Received | 1996-06-19 |
| Model Number | 1582 |
| Lot Number | 550824 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 34868 |
| Manufacturer | TANITA CORP OF AMERICA |
| Manufacturer Address | 5200 CHURCH ST SKOKIE IL 600771125 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-06-19 |