MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-02-25 for ACUITY H77-SIM manufactured by Varian Medical Systems.
[1485767]
The user reported that on two separate occasions during treatment planning creation in acuity, the multi leaf collimator shape for a beam created using the copy and oppose beam function is mirrored on the x-axis, instead of the y-axis. No serious injury to the pt was reported, as this event was observed by the user during treatment planning, and the plan was not used.
Patient Sequence No: 1, Text Type: D, B5
[8483596]
Based on the reported info, varian has been able to confirm the user's allegation: following plan creation at acuity, an image is acquired and grabbed to create a field from pt anterior to posterior (e. G ap field, ap image). An outline is drawn on the acquired image by the physician, outlining the areas to be treated. The multi leaf collimator is added and fitted to this outline. If the user creates an opposing field (pa field, pa image), the mlc are not correctly opposed (the mlc on the pa field are positioned exactly as on the ap field rather than in a mirrored position). If the user doesn't notice the incorrect placement of the mlc on the opposed field and if it isn't caught during plan review or approval for treatment, the pt can be treated with incorrectly placed mlc on the opposed field. It is standard clinical practice to acquire portal images on the first day of treatment. These image are reviewed and approved by the physician prior to starting treatment for single fraction treatments and typically before the second fraction for multiple fraction courses. Any misplacement of the mlc should be identified prior to treatment, and if not then during physician image review following the first treatment fraction. Thus, the pt would likely be treated for at most a single fraction with incorrect mlc. This problem has been determined to be isolated to the latest (current) release of the software. Add'l follow-up to this mdr is expected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8020711-2010-00002 |
| MDR Report Key | 1625245 |
| Report Source | 05,06 |
| Date Received | 2010-02-25 |
| Date of Report | 2010-01-28 |
| Date of Event | 2010-01-28 |
| Date Mfgr Received | 2010-01-28 |
| Device Manufacturer Date | 2004-11-01 |
| Date Added to Maude | 2011-10-03 |
| 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 | PAULO ALTO CA 94304 |
| Manufacturer Country | US |
| Manufacturer Postal | 94304 |
| Manufacturer Phone | 6504833153 |
| Manufacturer G1 | VARIAN MEDICAL SYSTEMS UK LTD. |
| Manufacturer Street | GATWICK RD., GRAWLEY |
| 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 | ACUITY |
| Generic Name | SIMULATOR |
| Product Code | KPQ |
| Date Received | 2010-02-25 |
| Model Number | H77-SIM |
| ID Number | V8.9 |
| 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 | 2010-02-25 |