MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-07-20 for ACUITY H77 manufactured by Varian Medical Systems Uk Ltd..
[2326045]
Acuity adds a fluence to non imrt field, this fluence belongs to another pt. The customer reports seeing irreg plans with a zigzag line in bev, indicating the presence of a fluence. Eclipse does not show an mlc object in the focus window, even though the mlc outline is visible in the bev. In rt chart, the mlc object is visible and the mlc can be exported. However, in irreg the mlc cannot be imported into that field because eclipse thinks (rightfully) than an mlc is present. But something is not right with it. It can't be deleted because it's not visible in the first place. (it is also impossible to insert a new mlc). The customer reports that they had this happen with irreg plans on a couple of occasions and once it happened for a non-imrt ct-based plan which (after simulation) had a fluence attached to one of the fields. We recognized this fluence as belonging to a breast pt who had been simulated earlier that day (with irregular surface compensator fluence) and this allowed us to understand at least a little bit of what is going on. There was no serious injury reported.
Patient Sequence No: 1, Text Type: D, B5
[9398106]
Although, there was no reported injury in this case, the available info suggest a possible malfunction of the device. Though still under investigation, varian has determined that a mdr is appropriate as this possible malfunction, should it recur, could potentially cause 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 | 8020711-2011-00008 |
| MDR Report Key | 2225490 |
| Report Source | 01,05,06 |
| Date Received | 2011-07-20 |
| Date of Report | 2011-06-23 |
| Date of Event | 2011-06-21 |
| Date Mfgr Received | 2011-06-23 |
| Device Manufacturer Date | 2004-11-01 |
| Date Added to Maude | 2012-06-19 |
| 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 |
| Reporter Occupation | PHYSICIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL PIGNATARO, MGR |
| Manufacturer Street | 911 HANSEN WAY M/S C-255 |
| 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 | ACCELERATOR, LINEAR, MEDICAL |
| Product Code | KPQ |
| Date Received | 2011-07-20 |
| Model Number | H77 |
| ID Number | 2.2.7 |
| 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 UK LTD. |
| Manufacturer Address | UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-20 |