MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-03-16 for DENT X 810 PROCESSOR MACH * manufactured by Mohawk Dental Supply Co., Inc..
[15006341]
According to the fire dept. Investigators, an electrical malfunction in a dental x-ray processing machine caused the wiring within the machine to overheat. This overheated wiring ignited part of the machine and nearby combustibles. The x-ray processing machine was a dent x 810 processor machine, installed by mohawk dental supply co. On 10/24/05. The room the equipment was located in was consumed by extensive fire damage. Smoke from the fire extended to other areas in the building and was difficult to ventilate, nearly required evacuation of the attached nursing facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1042254 |
| MDR Report Key | 829338 |
| Date Received | 2007-03-16 |
| Date of Report | 2007-03-09 |
| Date of Event | 2007-03-02 |
| Date Added to Maude | 2007-03-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DENT X |
| Generic Name | FILM PROCESSOR |
| Product Code | EGY |
| Date Received | 2007-03-16 |
| Model Number | 810 PROCESSOR MACH |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 816729 |
| Manufacturer | MOHAWK DENTAL SUPPLY CO., INC. |
| Manufacturer Address | * SYRACUSE NY 13206 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other | 2007-03-16 |