MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-05-10 for BUILT-IN CURING LIGTH ASSEMBLY FOR DENTAL CHAIR manufactured by Demetron Research Corp..
[22701]
The built-in curing light assembly has, on occasion, produced power surges which, in turn, causes the voltage regulator on the board to overload. This causes fuse 8 in the chair's power to blow. This fuse is in line with the 6v power supply needed to operate the curing light fan motor and the heated tubing circuit. Therefore, when the fuse blows, neither the curing light or the heated syringe (if applicable) will function.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4001180 |
| MDR Report Key | 32903 |
| Date Received | 1996-05-10 |
| Date of Report | 1995-10-04 |
| Date Added to Maude | 1996-05-15 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BUILT-IN CURING LIGTH ASSEMBLY FOR DENTAL CHAIR |
| Generic Name | LIGHT FOR DENTAL CHAIR |
| Product Code | KLC |
| Date Received | 1996-05-10 |
| ID Number | TD60078 |
| Operator | OTHER |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 34202 |
| Manufacturer | DEMETRON RESEARCH CORP. |
| Manufacturer Address | 5 YE OLDE RD DANBURY CT 06810 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-05-10 |