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 B7100C manufactured by Air Techniques Inc..
[117153788]
Customer reported flames coming from the external power. Customer was preparing to process images when the incident occurred. Transport was not yet activated and the unit was idle when she stated she saw flames coming from the external power supply. Per the customer there was no electrical storm or construction in the nearby vicinity. There were no reports of injury. No emergency services were contacted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2428225-2018-00004 |
| MDR Report Key | 7776792 |
| Date Received | 2018-08-13 |
| Date of Report | 2018-07-13 |
| Date of Event | 2018-07-12 |
| Date Mfgr Received | 2018-07-26 |
| Device Manufacturer Date | 2011-08-04 |
| 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 WHIMAN ROAD |
| Manufacturer City | MEVILLE 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 |
| Generic Name | SCANX IO |
| Product Code | MUH |
| Date Received | 2018-08-13 |
| Returned To Mfg | 2018-07-26 |
| Model Number | B7100C |
| 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, |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-13 |