MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-30 for SCANX CLASSIC ILE B7200 manufactured by Air Techniques Inc..
[109758315]
The device was returned without the power supply cord so a full evaluation could not be conducted. The power supply cord cannot be located.
Patient Sequence No: 1, Text Type: N, H10
[109758316]
The hygenist at the dental facility noticed in the afternoon that the external power supply cord on the back of the scanx unit was smoking. Unit was not being used at that time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2428225-2018-00003 |
| MDR Report Key | 7554982 |
| Date Received | 2018-05-30 |
| Date of Report | 2018-05-24 |
| Date of Event | 2018-04-26 |
| Date Mfgr Received | 2018-04-23 |
| Device Manufacturer Date | 2011-10-25 |
| Date Added to Maude | 2018-05-30 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CHRISTOPH ROEER |
| Manufacturer Street | 1295 WALT WHITMAN ROAD |
| Manufacturer City | MELVILLE NY 11747 |
| Manufacturer Country | US |
| Manufacturer Postal | 11747 |
| Manufacturer Phone | 5162145500 |
| Manufacturer G1 | AIR TECHNIQUES INC. |
| Manufacturer Street | 1295 WALT WHITMAN ROAD |
| Manufacturer City | MELVILLE NY 11747 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 11747 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SCANX CLASSIC ILE |
| Generic Name | SCANX CLASSIC |
| Product Code | MUH |
| Date Received | 2018-05-30 |
| Returned To Mfg | 2018-05-23 |
| Model Number | B7200 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AIR TECHNIQUES INC. |
| Manufacturer Address | 1295 WALT WHITMAN ROAD MELVILLE NY 11747 US 11747 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-30 |