MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-08-31 for DILON 6800 00-00014 manufactured by Dilon Technologies.
[2657486]
Following a training session at a new installation, the dillon trainer and an assistant repositioned the camera detector head for storage. The detector head detached from its mounting arm while it was being rotated into the storage position. The detachment is a safety concern. There were not pts present and no injury occurred.
Patient Sequence No: 1, Text Type: D, B5
[9890723]
Evaluation revealed that threaded inserts had pulled from the detector back plate. Inspection of all cameras incorporating the same detector mounting design is underway. Conclusions gained from this evaluation: it is likely that the inserts on 09-005 were "over torqued". It is unlikely than mounting screws used in the field were too long. It is unlikely that 8-32 x 9/16 shcs were used in the field. Heli-coils, properly installed and properly torqued, are stronger than required to maintain a safety factor of 10. Until the results are received from the metals testing house, no conclusion can be made to whether materials used are as specified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1125612-2009-00001 |
| MDR Report Key | 2596167 |
| Report Source | 07 |
| Date Received | 2009-08-31 |
| Date of Report | 2009-08-27 |
| Date Mfgr Received | 2009-07-24 |
| Device Manufacturer Date | 2009-06-30 |
| Date Added to Maude | 2012-06-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | LEE FAIRCHILD, VP OF ENGINEER |
| Manufacturer Street | 12050 JEFFERSON AVE. SUITE 340 |
| Manufacturer City | NEWPORT NEWS VA 23606 |
| Manufacturer Country | US |
| Manufacturer Postal | 23606 |
| Single Use | 0 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DILON 6800 |
| Generic Name | IYX - SCINTILLATION CAMERA |
| Product Code | IYX |
| Date Received | 2009-08-31 |
| Returned To Mfg | 2009-07-30 |
| Model Number | DILON 6800 |
| Catalog Number | 00-00014 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DILON TECHNOLOGIES |
| Manufacturer Address | NEWPORT NEWS VA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-08-31 |