MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-12-22 for XIMATRON H72-SIM manufactured by Varian Medical Systems.
[1418861]
Customer reports that symmetric/asymmetric properties of field are changing without intervention by the radiation therapists. As this change in symmetry can alter the field size, if it is not observed by the rtt's/physicist prior to initiation of treatment, an incorrect field size could be used for treatment. Based on the report, no pt injuries or mistreatment's have occurred.
Patient Sequence No: 1, Text Type: D, B5
[8514109]
Though still under investigation, varian has determined that a mdr is appropriate, as this malfunction, should it recur, could potentially cause a serious injury. Add'l f/u to this mdr is expected upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8020711-2009-00009 |
| MDR Report Key | 1579022 |
| Report Source | 05,06 |
| Date Received | 2009-12-22 |
| Date of Report | 2009-11-17 |
| Date of Event | 2009-11-17 |
| Date Mfgr Received | 2009-11-17 |
| Device Manufacturer Date | 2000-10-01 |
| Date Added to Maude | 2010-02-04 |
| 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. |
| Manufacturer City | CRAWLEY, 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 | 2009-12-22 |
| Model Number | H72-SIM |
| 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 |
| Manufacturer Address | PALO ALTO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-22 |