MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-04-03 for GX770 INTRAORAL X-RAY 46-404600G6 A0770JT manufactured by Gendex Dental Systems.
[811491]
After assistant took the x-ray and stored the x-ray head and arm in the home position, the tube head fell off the arm, and hit the floor.
Patient Sequence No: 1, Text Type: D, B5
[8049452]
The tube head and cone were damaged through the fall. There were no injuries. Doctor will decide whether to get the parts replaced or get a new x-ray.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004115000-2008-00005 |
| MDR Report Key | 1026507 |
| Report Source | 05 |
| Date Received | 2008-04-03 |
| Date of Report | 2008-03-04 |
| Date of Event | 2008-03-04 |
| Date Mfgr Received | 2008-03-04 |
| Device Manufacturer Date | 1990-08-15 |
| Date Added to Maude | 2008-09-16 |
| 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 | MARI LAMBERT, MGR |
| Manufacturer Street | 901 WEST OAKTON ST. |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| Manufacturer Phone | 8473643958 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GX770 INTRAORAL X-RAY |
| Generic Name | DENTAL X-RAY EQUIPMENT |
| Product Code | EAP |
| Date Received | 2008-04-03 |
| Model Number | 46-404600G6 |
| Catalog Number | A0770JT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1023518 |
| Manufacturer | GENDEX DENTAL SYSTEMS |
| Manufacturer Address | 901 WEST OAKTON ST. DES PLAINES IL 60018 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-04-03 |