MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-05-27 for GENDEX GXP DENTAL X-RAY PROCESSOR 112-0527G1 A0400 manufactured by Gendex Dental Systems.
[1398721]
The doctor stated that during operation of the dental x-ray film processor, the dryer fan stopped operating while the heater continued to operate. This resulted in the heater assembly overheating and starting on fire. The fire was localized to the film processor.
Patient Sequence No: 1, Text Type: D, B5
[8658400]
There was no property damage or user injury with this event. The top cover assembly of the film processor contains a fan and heater that operates during the drying of the film as part of the x-ray film processing. The fan creates the air flow over the heater for drying the x-ray film. The fan stopped working for unknown reasons possibly contributing to the overheating of the heater unit. The manufacturer has requested return of the fan and heater from the dental office for evaluation. The film processing unit has been repaired with a fan and heater replacement and is operational.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004115000-2010-00009 |
| MDR Report Key | 1701469 |
| Report Source | 06 |
| Date Received | 2010-05-27 |
| Date of Report | 2010-04-27 |
| Date of Event | 2010-04-27 |
| Date Mfgr Received | 2010-04-27 |
| Device Manufacturer Date | 1996-05-27 |
| Date Added to Maude | 2010-07-12 |
| 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 | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. DAWN BRAGG |
| Manufacturer Street | 901 WEST OAKTON STREET |
| Manufacturer City | DES PLAINES IL 600181884 |
| Manufacturer Country | US |
| Manufacturer Postal | 600181884 |
| Manufacturer Phone | 8473643290 |
| Manufacturer G1 | GENDEX DENTAL SYSTEMS |
| Manufacturer Street | 901 WEST OAKTON STREET |
| Manufacturer City | DES PLAINES IL 60018188 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60018 1884 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GENDEX GXP DENTAL X-RAY PROCESSOR |
| Generic Name | DENTAL X-RAY FILM PROCESSOR |
| Product Code | EGY |
| Date Received | 2010-05-27 |
| Model Number | 112-0527G1 |
| Catalog Number | A0400 |
| Operator | DENTIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENDEX DENTAL SYSTEMS |
| Manufacturer Address | 901 WEST OAKTON STREET DES PLAINES IL 60018188 US 60018 1884 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-05-27 |