MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-30 for AT2000XR 45000 manufactured by Air Techniques Inc..
[109758688]
Device was requested many times from customer to be returned for evaluation but customer decided not to return it. Evaluation could not be performed. On (b)(6) 2018 report was previously submitted on time with successful ack3s responses but on (b)(6) 2018 we noticed that the mfr report # on the original report was incorrect. We have corrected the mfr report # (2428225-2018-00001. )
Patient Sequence No: 1, Text Type: N, H10
[109758689]
Technician plugged in electrical connection between cover assembly and base unit before turning on the procecessor; he then heard the roller assemblies running and saw smoke at the round electrical connection. When he checked the electrical connection inside the unit he saw some wires with the insulation partially melted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2428225-2018-00001 |
| MDR Report Key | 7555018 |
| Date Received | 2018-05-30 |
| Date of Report | 2018-02-05 |
| Date of Event | 2018-02-05 |
| Date Mfgr Received | 2018-05-02 |
| Device Manufacturer Date | 2011-08-31 |
| 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 | MS. GRISELDA MADRID |
| Manufacturer Street | 1297 WALT WHITMAN ROAD |
| Manufacturer City | MELVILLE NY 11747 |
| Manufacturer Country | US |
| Manufacturer Postal | 11747 |
| Manufacturer Phone | 5162145541 |
| Manufacturer G1 | AIR TECHNIQUES INC. |
| Manufacturer Street | 1297 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 | AT2000XR |
| Generic Name | PROCESSOR, RADIOGRAPHIC, FILM AUTOMATIC |
| Product Code | IXW |
| Date Received | 2018-05-30 |
| Model Number | AT2000XR |
| Catalog Number | 45000 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 |