MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-01-15 for AXXENT 110 * manufactured by Xoft, A Subsidiary Of Icad.
[5424979]
There was a misadministration of the therapeutic dosage. Variation in calibration probe placement resulted in dosage other than the one intended due to incorrect calibration. The equipment design is integral to event. The probe for dosage does not "click" in place. The dose calibration varies with probe placement. The equipment does not alert user to "incorrect" calibration when calibration probe has moved, even slightly, out of the holder. The print out read "the treatment was delivered as planned". The equipment design for probe placement security is inadequate. A photograph will be e-mailed following this report. Also, note that the power cord has no uninterrupted power supply (ups), and ups is not recommended by manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4454786 |
| MDR Report Key | 4454786 |
| Date Received | 2015-01-15 |
| Date of Report | 2015-01-15 |
| Date of Event | 2014-04-16 |
| Report Date | 2015-01-15 |
| Date Reported to FDA | 2015-01-15 |
| Date Reported to Mfgr | 2015-01-27 |
| Date Added to Maude | 2015-01-27 |
| 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 |
| 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 | AXXENT |
| Generic Name | SYSTEM, THERAPEUTIC, X-RAY |
| Product Code | JAD |
| Date Received | 2015-01-15 |
| Model Number | 110 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XOFT, A SUBSIDIARY OF ICAD |
| Manufacturer Address | 101 NICHOLSON LANE SAN JOSE CA 95134 US 95134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-15 |