MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-26 for GENDEX GX-770 0.820.0146 manufactured by Dental Imaging Technologies Corporation.
[137561089]
The unit has not been returned to the manufacturer for evaluation. A cause as to the malfunction of the unit component cannot be determined. The actual date of manufacture cannot be determined; however, the gx-770 was discontinued from sale on 03/31/2010 and manufacturer support of the device ended on 03/31/2017. This concludes the investigation.
Patient Sequence No: 1, Text Type: N, H10
[137561090]
It was reported the horizontal arm broke loose where it meets the control panel. There was no report of patient or user involvement. No injuries were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530069-2019-00001 |
| MDR Report Key | 8369709 |
| Date Received | 2019-02-26 |
| Date of Report | 2019-02-26 |
| Date of Event | 2019-02-04 |
| Date Mfgr Received | 2019-02-04 |
| Date Added to Maude | 2019-02-26 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ERIKA MARTIN |
| Manufacturer Street | 1910 NORTH PENN ROAD |
| Manufacturer City | HATFIELD PA 19440 |
| Manufacturer Country | US |
| Manufacturer Postal | 19440 |
| Manufacturer Phone | 2159975666 |
| Manufacturer G1 | GENDEX DENTAL SYSTEMS |
| Manufacturer Street | 1910 NORTH PENN DRIVE |
| Manufacturer City | HATFIELD PA 19440 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19440 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GENDEX GX-770 |
| Generic Name | UNIT, X-RAY, EXTRAORAL WITH TIMER |
| Product Code | EHD |
| Date Received | 2019-02-26 |
| Model Number | GX-770 |
| Catalog Number | 0.820.0146 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTAL IMAGING TECHNOLOGIES CORPORATION |
| Manufacturer Address | 1910 NORTH PENN ROAD HATFIELD PA 19440 US 19440 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-26 |