MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2008-07-10 for SEDECAL X-PLUS LP manufactured by Sedecal S.a..
[896840]
The device is a stationary diagnostic x-ray system with a motorized "c-arm" tubehead/bucky assembly. The technologist was preparing to do foot study. The tube was rotated to point down to the floor. The first exposure was taken. Preparing to make a standing foot exposure, the c-arm was then angled to less than 90 degrees with the tube pointing to the floor. The technologist adjusted the tube (sid) reducing the distance between the tube and the bucky to improve the alignment to the digital sensor. While the tube was moving, an error was displayed on the led indicator. The tech was not sure of the error code; maybe -31. At this point, the system froze. The tech was unable to make the system respond. She rebooted the system. During the booting process the led display flashed an error code with a line through it. The lcd display had lines through the display and was also flashing. Tech then tried to move the carriage down by depressing the down button at the control panel but it did not respond. She released the down button and suddenly the carriage began to move down slowly. The carriage continued to move down to the floor. The steel cable began to unwind after the carriage came into contact with the floor. After hearing a noise from the rear of the unit the tech hit the emergency stop button and the motion stopped.
Patient Sequence No: 1, Text Type: D, B5
[7885175]
The diagnostic x-ray system experienced uncommanded movement of the tube-head/bucky assembly (aka "c-arm"). An upgrade to the control logic has been made to systems manufactured during and after april 2007. This upgrade prevents uncommanded system movement. The system that malfunctioned had not received this upgrade. The system was repaired and the upgrade applied. Sedecal had prepared a list of all systems requiring the upgrade and is in the process of applying the upgrade to all affected systems in the field.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9617251-2008-00001 |
| MDR Report Key | 1076163 |
| Report Source | 05,07 |
| Date Received | 2008-07-10 |
| Date of Report | 2008-07-10 |
| Date of Event | 2008-04-10 |
| Date Mfgr Received | 2008-04-10 |
| Device Manufacturer Date | 2006-05-15 |
| Date Added to Maude | 2009-04-16 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 2920 N. ARLINGTON HEIGHTS ROAD |
| 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 | RP |
| 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 | 2008-07-10 |
| Model Number | X-PLUS LP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SEDECAL S.A. |
| Manufacturer Address | MADRID SP |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-07-10 |