MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2011-03-14 for SEDECAL FLEXI-DT manufactured by Sedecal S.a. Algete.
[1920088]
This event involves a powered x-ray table. The operator reportedly rec'd an electric shock while he was connecting the power supply cord to the table. The power cord was already connected to the wall socket. The operator used the cord in a visibly damaged state. The system had been in use for more than 5 years. This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[9092261]
The root cause of this event is improper maintenance coupled with user error.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9617251-2011-00001 |
| MDR Report Key | 2023842 |
| Report Source | 01,08 |
| Date Received | 2011-03-14 |
| Date of Report | 2011-03-08 |
| Date of Event | 2011-11-24 |
| Date Mfgr Received | 2011-02-23 |
| Device Manufacturer Date | 2005-11-01 |
| Date Added to Maude | 2011-03-22 |
| 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 | 230 LEXINGTON DR. |
| Manufacturer City | BUFFALO GROVE IL 60089 |
| Manufacturer Country | US |
| Manufacturer Postal | 60089 |
| Manufacturer Phone | 8473946960 |
| Manufacturer G1 | SEDECAL S.A. |
| Manufacturer Street | PELAYA, 9- POLIGONO INDUSTRIAL |
| Manufacturer City | RIO DE JANEIRO, MADRIS |
| 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 | X-RAY TABLE |
| Product Code | IZZ |
| Date Received | 2011-03-14 |
| Model Number | FLEXI-DT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SEDECAL S.A. ALGETE |
| Manufacturer Address | MADRID SP |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-03-14 |