MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-10-21 for ACUITY H77-SIM manufactured by Varian Medical Systems.
[1664459]
The customer reported that they opposed a field, but the mlc did not oppose as they should. The customer was a bit concerned that if somehow the therapists forgot and this was missed, it could lead to patient mistreatment. No serious injury to the patient was reported and no patient data provided.
Patient Sequence No: 1, Text Type: D, B5
[8855223]
Based on the reported information, 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 patient 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 does not notice the incorrect placement of the mlc on the opposed field and if it is not caught during plan review or approval for treatment, the patient can be treated with incorrectly placed mlc on the opposed field. An internal corrective action was initiated to further evaluate any further design improvement. As a result, a future release of the acuity software will contain a correction. In order to mitigate recurrence of this issue for current acuity users, a customer technical bulletin (ctb) will be provided to further describe the behavior and instruct on the available workaround. No additional follow-up to this mdr is expected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8020711-2010-00009 |
| MDR Report Key | 1883359 |
| Report Source | 05,06 |
| Date Received | 2010-10-21 |
| Date of Report | 2010-09-28 |
| Date of Event | 2010-09-28 |
| Date Mfgr Received | 2010-09-28 |
| Device Manufacturer Date | 2009-12-01 |
| Date Added to Maude | 2012-01-17 |
| 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 |
| Manufacturer City | PALO ALTO CA 94304 |
| Manufacturer Country | US |
| Manufacturer Postal | 94304 |
| Manufacturer Phone | 6504246471 |
| 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 | ACUITY |
| Generic Name | SIMULATOR |
| Product Code | KPQ |
| Date Received | 2010-10-21 |
| Model Number | H77-SIM |
| ID Number | V8.9.09 |
| 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 | 2010-10-21 |