MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-12 for DCI EQUIPMENT DC1335 manufactured by Dci Equipment.
[105536465]
The chair pcb is located in a fire resistant housing per the required electrical and safety requirements of iec 60601-1 (medical electrical equipment - part 1: general requirements for basic safety and essential performance). Dci equipment contacted the dental facility numerous times trying to obtain more information regarding this event as well as to request the part back for evaluation however dci equipment was continually routed back to a call center for the dental practice on all attempts made. Several messages were left with the facility but they never returned our calls. Therefore we are unable to evaluate the failed component.
Patient Sequence No: 1, Text Type: N, H10
[105536466]
It was reported by the doctor's service technician that a dci equipment dental chair's circuit board located in the chair base assembly started to smoke and caught fire. There were no injuries reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-2018-00010 |
| MDR Report Key | 7427016 |
| Date Received | 2018-04-12 |
| Date of Report | 2018-03-15 |
| Date Mfgr Received | 2018-03-15 |
| Device Manufacturer Date | 2014-12-01 |
| Date Added to Maude | 2018-04-12 |
| 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 PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. FRANK RAY |
| Manufacturer Street | 11727 FRUEHAUF DRIVE |
| Manufacturer City | CHARLOTTE NC 28273 |
| Manufacturer Country | US |
| Manufacturer Postal | 28273 |
| Manufacturer Phone | 7045877227 |
| Manufacturer G1 | KAVO DENTAL TECHNOLOGIES, LLC |
| Manufacturer Street | 11727 FRUEHAUF DRIVE |
| Manufacturer City | CHARLOTTE NC 28273 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 28273 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DCI EQUIPMENT |
| Generic Name | DENTAL CHAIR |
| Product Code | NRU |
| Date Received | 2018-04-12 |
| Model Number | DC1335 |
| Catalog Number | DC1335 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DCI EQUIPMENT |
| Manufacturer Address | 11727 FRUEHAUF DRIVE CHARLOTTE NC 28273 US 28273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-12 |