MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-04-20 for SUINSA (MARKETED BY CARESTREAM) NOVA manufactured by Suinsa.
[1298763]
The technician was positioning the otc (overhead tube crane) over a pt on the table for a lateral exam. The technician pressed the "alpha" button, also inadvertently pressing the "all" button on the otc operator handle. The otc motor drove the otc vertically downward at a higher than usual rate of speed. The operator did not release the "all" button quickly enough to prevent pt contact. The otc contacted the pt with some amount of force in the hip area. The pt saw a physician on (b)(6) 2009. No injury was diagnosed.
Patient Sequence No: 1, Text Type: D, B5
[8535068]
The strain gauge (wheatstone bridge that measures operator effort) signal will be evaluated prior to vertical servo motor assistance is connected/enabled. Strain gauge signal will be now measured by a new revision of the board that monitors the activation/deactivation of the otc (overhead tube crane) handle buttons. At the moment that any dead man button that demands vertical assisted movement is enabled by operator ("all" or "vertical") if the strain gauge effort readout is not 0 (or close to, due to tolerance band) such board will ignore such button demand. Therefore if strain gauge malfunction occurs (like incident described), whenever operator tries to move otc vertical axis by depressing button, the new revision board will detect a non close to 0 effort and therefore such button depress will be completely ignored and the motor servo assistance will not be connected at all.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000404222-2009-00002 |
| MDR Report Key | 1669061 |
| Report Source | 05,06 |
| Date Received | 2010-04-20 |
| Date of Report | 2009-09-09 |
| Date of Event | 2009-08-11 |
| Date Mfgr Received | 2009-09-02 |
| Device Manufacturer Date | 2008-08-08 |
| Date Added to Maude | 2010-11-10 |
| 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 | RADIOLOGIC TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. RANDY DUFFY |
| Manufacturer Street | 2920 N. ARLINGTON HEIGHTS RD |
| Manufacturer City | ARLINGTON HEIGHTS IL 60004 |
| Manufacturer Country | US |
| Manufacturer Postal | 60004 |
| Manufacturer Phone | 8473946960 |
| Manufacturer G1 | SUINSA |
| Manufacturer Street | C/. PRIMAVERA, 39 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 (MARKETED BY CARESTREAM) |
| Generic Name | TUBE MOUNT, X-RAY, DIAGNOSTIC, IYB |
| Product Code | IYB |
| Date Received | 2010-04-20 |
| 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 | C/. PRIMAVERA, 39 PARQUE IND LAS MOJAS TORREJON DE ARDOZ MADRID 28850 SP 28850 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-04-20 |