MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2011-01-06 for XIMATRON C RADIOTHERAPY TREATMENT SIMULATOR XIM-CX manufactured by Varian Medical Systems Uk Ltd.
[15207094]
Treatment fields were deleted by the system during simulation. Upon saving the images, a system warning message appeared, stating that one according field would not exist for one of the image geometry and was deleted. No other errors or messages.
Patient Sequence No: 1, Text Type: D, B5
[15794116]
No serious injury was reported as a result of this malfunction. It is believed unlikely, however, if the field were deleted and the operator did not notice, and no subsequent practices caught the error, treatment could result in an underdose. Though still under investigation, varian has determined that a mdr is appropriate as this malfunction, should it recur, could potentially cause serious injury. Additional follow-up to this mdr is expected upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8020711-2010-00010 |
| MDR Report Key | 1961444 |
| Report Source | 01,05 |
| Date Received | 2011-01-06 |
| Date of Report | 2010-12-21 |
| Date of Event | 2010-11-15 |
| Date Mfgr Received | 2010-12-21 |
| Device Manufacturer Date | 1997-02-01 |
| Date Added to Maude | 2012-01-26 |
| 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 | MICHAEL PIGNATARO, MANAGER |
| Manufacturer Street | 911 HANSEN WAY, M/S C-255 |
| Manufacturer City | PALO ALTO CA 84304 |
| Manufacturer Country | US |
| Manufacturer Postal | 84304 |
| Manufacturer Phone | 6504246471 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XIMATRON C RADIOTHERAPY TREATMENT SIMULATOR |
| Generic Name | SYSTEM, SIMULATION, RADIATION THERAPY |
| Product Code | KPQ |
| Date Received | 2011-01-06 |
| Model Number | XIM-CX |
| ID Number | 8.2.24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VARIAN MEDICAL SYSTEMS UK LTD |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-01-06 |