MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-13 for SCANX IO ILE B7100 manufactured by Air Techniques Inc..
[117165802]
Customer reported smoking/melted external power cord. The caller noticed the smoking power cord in back of the scanx unit. The customer then unplugged the power cord from the wall. There were no reports of injury. No emergency services were contacted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2428225-2018-00005 |
| MDR Report Key | 7777835 |
| Date Received | 2018-08-13 |
| Date of Report | 2018-08-13 |
| Date of Event | 2018-07-16 |
| Date Mfgr Received | 2018-08-01 |
| Device Manufacturer Date | 2010-09-03 |
| Date Added to Maude | 2018-08-13 |
| 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. JOSEPH LATKOWSKI |
| Manufacturer Street | 1295 WALT WHITMAN ROAD |
| Manufacturer City | MELVILLE NY 11747 |
| Manufacturer Country | US |
| Manufacturer Postal | 11747 |
| Manufacturer Phone | 5162145574 |
| 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 IO ILE |
| Generic Name | SCANX IO ILE |
| Product Code | MUH |
| Date Received | 2018-08-13 |
| Returned To Mfg | 2018-08-01 |
| Model Number | B7100 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-08-13 |