MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-12 for MODEL I 128 A2D2 LOGO, MODEL I 128 PODIATRY manufactured by Ann Arbor Digital Devices.
[16988786]
A podiatry x-ray machiner has been modified by a2d2 to product digital x-rays. The modification has changed the original manufacturers sid. The change in sid violates the liquid distance between x-ray tube and subject causing an increase in radiation exposure to the patient. A cannon rebel t3i slr camera is used to capture the x-ray image. How can this be so.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5038200 |
| MDR Report Key | 4096455 |
| Date Received | 2014-09-12 |
| Date of Report | 2014-09-09 |
| Date of Event | 2014-09-08 |
| Date Added to Maude | 2014-09-18 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MODEL I 128 |
| Generic Name | MODEL I 128 |
| Product Code | NVV |
| Date Received | 2014-09-12 |
| Model Number | A2D2 LOGO, MODEL I 128 PODIATRY |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANN ARBOR DIGITAL DEVICES |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-09-12 |