MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-04-13 for XIMATRON manufactured by Varian Medical Systems.
[19286712]
Varian received a call from an attorney calling on behalf of (b)(6). It was reported that in (b)(6) 2008, the hospital had a pt that "rolled herself off" the table during treatment - on a varian xim. The attorney did not provide any other pt info. The device model and serial number was not provided and there was no allegation that the incident was the fault of varian or related to any device defect.
Patient Sequence No: 1, Text Type: D, B5
[19340855]
The hospital representative would not provide any add'l details regarding the incident or pt info. However, the machine has been removed and is no longer at the facility. Varian has determined that a mdr is appropriate, due to the indication of injury. No add'l f/u to this mdr is expected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8020711-2010-00004 |
| MDR Report Key | 1662416 |
| Report Source | 05,06 |
| Date Received | 2010-04-13 |
| Date of Report | 2010-03-18 |
| Date Added to Maude | 2012-03-14 |
| 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 | DAVID HALL, MGR |
| Manufacturer Street | 911 HANSEN WAY |
| Manufacturer City | PALO ALTO CA 94304 |
| Manufacturer Country | US |
| Manufacturer Postal | 94304 |
| Manufacturer Phone | 6504833153 |
| Manufacturer G1 | VARIAN MEDICAL SYSTEMS UK LTD. |
| Manufacturer Street | GATWICK RD. CRAWLEY |
| Manufacturer City | WEST SUSSEX RH109RG |
| Manufacturer Country | UK |
| Manufacturer Postal Code | RH10 9RG |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XIMATRON |
| Generic Name | SYSTEM, SIMULATION, RADIATION THERAPY |
| Product Code | KPQ |
| Date Received | 2010-04-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VARIAN MEDICAL SYSTEMS |
| Manufacturer Address | PALO ALTO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-04-13 |