MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-09 for AT2000 XR AT2000XR 45000 manufactured by Air Techniques Inc..
[82677348]
A field service technician reported receiving an electrical shock from the at2000 xr device. The device is installed in a private dental office.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2428225-2017-00001 |
| MDR Report Key | 6777948 |
| Date Received | 2017-08-09 |
| Date of Report | 2017-07-18 |
| Date of Event | 2017-07-10 |
| Date Mfgr Received | 2017-07-10 |
| Device Manufacturer Date | 1999-03-23 |
| Date Added to Maude | 2017-08-09 |
| 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 | MS. GRISELDA MADRID |
| Manufacturer Street | 1295 WALT WHITMAN ROAD |
| Manufacturer City | MELVILLE NY 11747 |
| Manufacturer Country | US |
| Manufacturer Postal | 11747 |
| Manufacturer Phone | 5162145541 |
| Manufacturer G1 | AIR TECHNIQUES |
| 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 | AT2000 XR |
| Generic Name | PROCESSOR, RADIOGRAPHIC, FILM AUTOMATIC |
| Product Code | IXW |
| Date Received | 2017-08-09 |
| Model Number | AT2000XR |
| Catalog Number | 45000 |
| Lot Number | N/A |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2017-08-09 |