MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2007-10-22 for SEDECAL SEDECAL X-PLUS A8114-10 manufactured by Sedecal S.a..
[742279]
The positioner was in the undertable position, sid at 100cm and with a patient on a quantum table. While the x-ray technician was positioning the patient on the table, they noticed the u-arm positioner start to move in the downward position by itself. The technician quickly move the patient off the table to avoid the patient being hit by the moving tube/collimator assembly. They then noticed the positioner start to travel in the upward position on its own, with the table still over the bucky. It actually lifted the several hundred pound table completely off the floor. The positioner continued to move up past the height motor limit switches, crushing the mechanical stops. The carriage cable came completely off the pulley, wrapping around the height potentiometer bracket. Besides the major safety issue here, severe damage occurred to the positioner. The patient was not injured.
Patient Sequence No: 1, Text Type: D, B5
[7862091]
The diagnostic x-ray system experienced uncommanded movement of the tube-head/bucky assembly. The actual cause of this movement is unknown as of the date of this report. However and upgrade to the control logic has been made to systems manufactured during and after april 2007 has been implemented. This upgrade prevents uncommanded system movement. The system that malfunctions had not received this upgrade. The system was replaced and the system that malfunctioned has been sent to sedecal usa for further evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9617251-2007-00002 |
| MDR Report Key | 931387 |
| Report Source | 05,07 |
| Date Received | 2007-10-22 |
| Date of Report | 2007-10-22 |
| Date of Event | 2007-09-21 |
| Date Mfgr Received | 2007-09-26 |
| Device Manufacturer Date | 2007-04-15 |
| Date Added to Maude | 2007-12-14 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 2920 N. ARLINGTON HEIGHTS RD. |
| Manufacturer City | ARLINGTON HEIGHTS IL 60006 |
| Manufacturer Country | US |
| Manufacturer Postal | 60006 |
| Manufacturer Phone | 8473946960 |
| Manufacturer G1 | SEDECAL S.A. |
| Manufacturer Street | PELAYA, 9 POLIGONO INDUSTRIAL RIO DE JANEIRO |
| Manufacturer City | MADRID |
| Manufacturer Country | SP |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SEDECAL |
| Generic Name | DIAGNOSTIC X-RAY SYSTEM |
| Product Code | IZO |
| Date Received | 2007-10-22 |
| Returned To Mfg | 2007-10-19 |
| Model Number | SEDECAL X-PLUS |
| Catalog Number | A8114-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 926334 |
| Manufacturer | SEDECAL S.A. |
| Manufacturer Address | MADRID SP |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-10-22 |