MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-09-09 for SCANX D1000K manufactured by Air Techniques, Inc..
[4697856]
Complaint was received for a scanx duo ((b)(4), date of mfr, 01/21/2011). The implicated scanx duo was manufactured 01/21/2011 and has been in service for two years. Observations: the unit was tampered with because we observed that the bottom fuse tab was missing. The rear cover screws were loose. The main pcb was inspected and there were no visible burn markings or burnt components. The internal power supply was removed and there was a burn mark on the main cavity next to it. The implicated unit was in use for nearly two years when the internal power supply failed, rendering the unit inoperable. The failure of the power supply is deemed an isolated incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2428225-2014-00003 |
| MDR Report Key | 4105448 |
| Report Source | 08 |
| Date Received | 2014-09-09 |
| Date of Report | 2014-09-09 |
| Date of Event | 2013-01-03 |
| Date Mfgr Received | 2013-01-18 |
| Device Manufacturer Date | 2011-01-21 |
| Date Added to Maude | 2014-09-29 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1295 WALT WHITMAN RD. |
| Manufacturer City | MELVILLE NY 11747 |
| Manufacturer Country | US |
| Manufacturer Postal | 11747 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCANX |
| Generic Name | DIGITAL IMAGING SYSTEM |
| Product Code | MUH |
| Date Received | 2014-09-09 |
| Model Number | D1000K |
| Catalog Number | D1000K |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AIR TECHNIQUES, INC. |
| Manufacturer Address | MELVILLE NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-09-09 |