MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-13 for PANORAMIC CCD ENCOMPASS 801413-1 manufactured by Young Innovations.
[111440770]
The technician has tested wires to make sure there aren't any other short circuits with the machine. He replaced the capacitor board, tubehead, and cable 58. The machine is working now. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[111440771]
The aps technician, (b)(6), was at the office working on the machine and replaced cable 58 on the machine. When the machine was powered on, the capacitor board started crackling and then burst into flames. The technician had to put the fire out with his sweater. The aps technician was not physically injured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1832462-2018-00004 |
| MDR Report Key | 7598029 |
| Date Received | 2018-06-13 |
| Date of Report | 2018-06-13 |
| Date of Event | 2018-06-05 |
| Date Mfgr Received | 2018-06-05 |
| Device Manufacturer Date | 2014-09-02 |
| Date Added to Maude | 2018-06-13 |
| 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 |
| Reporter Occupation | SERVICE AND TESTING PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ADRIENNE DEMLAND |
| Manufacturer Street | 4321 GOSHEN RD. |
| Manufacturer City | FORT WAYNE IN 46818 |
| Manufacturer Country | US |
| Manufacturer Postal | 46818 |
| Manufacturer Phone | 8006542027 |
| Manufacturer G1 | YOUNG INNOVATIONS |
| Manufacturer Street | 4321 GOSHEN RD. |
| Manufacturer City | FORT WAYNE IN 46818 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46818 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PANORAMIC CCD ENCOMPASS |
| Generic Name | CCD ENCOMPASS |
| Product Code | MUH |
| Date Received | 2018-06-13 |
| Model Number | 801413-1 |
| Operator | SERVICE AND TESTING PERSONNEL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | YOUNG INNOVATIONS |
| Manufacturer Address | 4321 GOSHEN RD. FORT WAYNE IN 46818 US 46818 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-13 |