MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-06-19 for SIEMENS BRAND NAME: SIMVIEW 3000 4115 manufactured by Siemens Medical Solutions Usa, Inc..
[1102754]
A potential product issue has been reported with our simview 3000 simulator. In the abundance of caution, this issue is being reported. During the simulation, the image amplifier moved under the pt-table and deformed it. There was no propulsion command for this motion and there was no interruption by sw limits or hw switches. The system was cut off with the emergency stop. There was no report of mistreatment, injury and/or death reported. Investigation for root cause has been initiated. Final corrective action is pending. Risk analysis complete.
Patient Sequence No: 1, Text Type: D, B5
[8437710]
Risk assessment indicates: severity: 2 (moderate), reason: sudden amplifier movement (non-user triggered! ) may cause pt crushing injuries if they remain undetected by the user. Probability: d (occasional), reason: (0. 01-0. 1 occurrences in 1000 (0. 001%-0. 01%), improbably, but not impossible). The operator of the systems is obliged to watch the pt during the simulation and to intervene if needed, for user intervention, multiple mechanisms are available to avoid serious injury: an interrupt mechanism based on sw limits or hw switches. The system provides an touch gard as well as a motion stop, the room provides an emergency power off button. Per the instructions for use (5604004 rev. B), the user shall daily check the functionality of the touch gard, motion enable switch, and emergency off. No other products are affected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2910081-2009-00041 |
| MDR Report Key | 1406009 |
| Report Source | 07 |
| Date Received | 2009-06-19 |
| Date of Report | 2009-05-19 |
| Date of Event | 2009-05-19 |
| Date Mfgr Received | 2009-05-19 |
| Device Manufacturer Date | 1997-10-01 |
| Date Added to Maude | 2010-02-02 |
| 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 Contact | MARK BURGESS |
| Manufacturer Street | 4040 NELSON AVE. |
| Manufacturer City | CONCORD CA 94520 |
| Manufacturer Country | US |
| Manufacturer Postal | 94520 |
| Manufacturer Phone | 9256028083 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIEMENS BRAND NAME: SIMVIEW 3000 |
| Generic Name | RADIATION THERAPY SIMULATION SYSTEM |
| Product Code | KPQ |
| Date Received | 2009-06-19 |
| Model Number | NA |
| Catalog Number | 4115 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| Manufacturer Address | 4040 NELSON AVE. CONCORD CA 94520 US 94520 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-06-19 |