MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2012-12-11 for ARTISTE MV SYSTEM 08139789 NA manufactured by Siemens Medical Solutions Usa, Inc., Radiation Oncology.
[3304497]
Siemens was notified on (b)(6) 2012 that the 333 was the position information on the table interface when the table was in the physical 0 degree position. The position readout changed when doing isocentric rotation. It behaved exactly like someone had rotated the table to 333 degrees and done a calibration saying this is zero. Reportedly the therapist had transferred patient data from (b)(4) to rt therapist and downloaded the first field to the accelerator. The requested isocentric rotation for the treatment field was zero. When the therapists were in the treatment room and pushed the button for auto-setup, the table moved isocentric even though the table was physically correct at zero (0) degrees. Then it was noticed that the readout display showed 333 when the physical position was at zero (0) degrees. There was no error message. The table had to be re-calibrated to bet the correct readout. There is no report of injury to the patient. This reported issue occurred in (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[10349970]
Siemen? S investigation into the reported incident is on-going. A supplemental report will be sent to the fda upon completion of the investigation. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2910081-2012-10524 |
| MDR Report Key | 2917640 |
| Report Source | 01,05,07 |
| Date Received | 2012-12-11 |
| Date of Report | 2012-11-12 |
| Date of Event | 2012-10-23 |
| Date Mfgr Received | 2012-11-12 |
| Date Added to Maude | 2013-03-15 |
| 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 | 4040 NELSON AVE. |
| Manufacturer City | CONCORD CA 94520 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94520 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTISTE MV SYSTEM |
| Generic Name | ACCELERATOR, LINEAR, MEDICAL |
| Product Code | JAI |
| Date Received | 2012-12-11 |
| Model Number | 08139789 |
| Catalog Number | NA |
| Lot Number | NA |
| 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., RADIATION ONCOLOGY |
| Manufacturer Address | 4040 NELSON AVE. CONCORD CA 94520 US 94520 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-11 |