MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-05-07 for SUINSA NOVA manufactured by Suinsa.
[1214623]
The pt was lying on the table while technicians were in the control booth adjusting an image size (on the canon system) to send to the printer. The elite system had not been set up yet for the pt on the table. Technician heard the pt say "ouch. " when he looked up, he saw the tube crane had lowered onto the pt's foot. He ran over to the table and tried to lift the tube off the pt's foot, but it was still driving downward. Technician was able to reach one of the table foot switches to cancel the command. At that point, the tube stopped driving down and he was able to lift the tube up off of the pt's foot. According to technicians, the pt was unharmed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000404222-2009-0001 |
| MDR Report Key | 1439060 |
| Report Source | 06 |
| Date Received | 2009-05-07 |
| Date of Report | 2009-05-05 |
| Date of Event | 2009-04-07 |
| Date Mfgr Received | 2009-05-01 |
| Date Added to Maude | 2009-09-22 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | RANDY DUFFY |
| Manufacturer Street | 2920 N. ARLINGTON HEIGHTS RD |
| Manufacturer City | ARLINGTON HEIGHTS IL 60004 |
| Manufacturer Country | US |
| Manufacturer Postal | 60004 |
| Manufacturer G1 | SUINSA |
| Manufacturer Street | C/. PRIMAVERA, 39 PARQUE IND. LAS MOJAS TORREJON DE ARDOZ |
| Manufacturer City | MADRID 28850 |
| Manufacturer Country | SP |
| Manufacturer Postal Code | 28850 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUINSA |
| Generic Name | DIAGNOSTIC X-RAY SYSTEM |
| Product Code | IZO |
| Date Received | 2009-05-07 |
| Model Number | NOVA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUINSA |
| Manufacturer Address | MADRID SP |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-05-07 |