MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 1999-05-20 for MULTILEAF COLLIMATOR W/DYNAMIC ARC THERAPY 52-LEAF, 80-LEAF, 120-LEAF * manufactured by Varian Oncology Systems.
[142327]
A customer reported an anomaly in their multi-leaf collimator (mlc) during quality assurance checks of a mlc dynamic arc plan. The mlc leaf positions where found to be incorrect during a "shaped port film check. There was no pt involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2914292-1999-00002 |
| MDR Report Key | 225006 |
| Report Source | 05,07 |
| Date Received | 1999-05-20 |
| Date of Report | 1999-05-19 |
| Date of Event | 1999-03-22 |
| Device Manufacturer Date | 1998-08-01 |
| Date Added to Maude | 1999-05-27 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MULTILEAF COLLIMATOR W/DYNAMIC ARC THERAPY |
| Generic Name | RADIATION THERAPY MULTILEAF COLLIMATOR |
| Product Code | IXI |
| Date Received | 1999-05-20 |
| Model Number | 52-LEAF, 80-LEAF, 120-LEAF |
| Catalog Number | * |
| Lot Number | * |
| ID Number | SOFTWARE VERS. 4.2 TO (MORE) |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 218186 |
| Manufacturer | VARIAN ONCOLOGY SYSTEMS |
| Manufacturer Address | 911 HANSEN WAY PALO ALTO CA 94304 US |
| Baseline Brand Name | MULTILEAF COLLIMATOR W/DYNAMIC ARC THERAPY |
| Baseline Generic Name | RADIATION THERAPY MULTILEAF COLLIMATOR |
| Baseline Model No | 52-LEAF, 80-LEA |
| Baseline Catalog No | * |
| Baseline ID | SOFTWARE VERS. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-05-20 |