MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-09-25 for SIMVIEW NT WITH IDI 05497016 NA manufactured by Siemens Medical Solutions Usa, Inc., Radiation Oncology.
[16552954]
Siemens u. S. Was notified on september 2, 2013 that during a service call on (b)(4) 2013, siemens' customer service engineer (cse) rotated the gantry by using the hand control. However, when the button to stop rotation was pressed, the motion switch was released and the same command given on the touch screen, the gantry rotation did not stop. Reportedly, the cse pressed the yellow emergency button at the hand control but the gantry rotation still did not stop. Then, the cse turned off the f1 fuse to dis-energize the system; however, it had already "crashed. " there is no report of mistreatment or injury to a patient. This reported issue occurred in (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[16709020]
Siemens u. S. Became aware of the reported event on september 2, 2013. This mdr is being mailed on september 24, 2013. Siemens' investigation into the reported event is ongoing. A supplemental report will be submitted to the fda upon completion of the investigation. Customer address: (b)(6). Brand name: simview nt, p/n 5496992 and simview nt with idi, p/n 5497016 are both affected products for the reported problem.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2910081-2013-07739 |
| MDR Report Key | 3456084 |
| Report Source | 01,07 |
| Date Received | 2013-09-25 |
| Date of Report | 2013-07-24 |
| Date of Event | 2013-07-24 |
| Date Mfgr Received | 2013-07-24 |
| Date Added to Maude | 2014-01-03 |
| 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 | MARLYNNE GALLOWAY |
| Manufacturer Street | 51 VALLEY STREAM PKWY, MS D02 |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6102195361 |
| Manufacturer G1 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| Manufacturer Street | 757A ARNOLD DR |
| Manufacturer City | MARTINEZ CA 94553 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94553 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIMVIEW NT WITH IDI |
| Generic Name | SYSTEM, SIMULATION, RADIATION THERAPY |
| Product Code | KPQ |
| Date Received | 2013-09-25 |
| Model Number | 05497016 |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS USA, INC., RADIATION ONCOLOGY |
| Manufacturer Address | 757A ARNOLD DR MARTINEZ CA 94553 US 94553 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-25 |