MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-07-26 for ACUITY H77 manufactured by Varian Medical Systems Uk Ltd..
[19186174]
Varian initiated eval of the acuity, for the possibility of the wrong energy being used for dose calculation as reported in eclipse version 10. It has been previously reported that with eclipse version 10, that a copy, paste and recalculation can be performed for a pt plan and that incorrect beam energy is used for the beams in the copied and paste plan. If the user edits the energy in the copied plan then reverts, without user intervention, back to the energy in the original plan; the calculated mu and isodoses are not invalidate. The root cause of this issue in the eclipse product has been traced to corrupt handling of database cache. It has been requested by varian engineering, that this issue, reported for the eclipse products, be evaluated to see if the same (or similar) risk applies to the acuity products. There have been no occurrences of this issue reported in the acuity product.
Patient Sequence No: 1, Text Type: D, B5
[19429441]
Although there have been reports of this issue in the acuity product line, the available info suggests it may be possible to reproduce this or similar issue in acuity. 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 | 8020711-2011-00010 |
| MDR Report Key | 2231341 |
| Report Source | 07 |
| Date Received | 2011-07-26 |
| Date of Report | 2011-06-29 |
| Date of Event | 2011-06-29 |
| Date Mfgr Received | 2011-06-29 |
| Date Added to Maude | 2012-06-15 |
| 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, 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 | 2011-07-26 |
| Model Number | H77 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2011-07-26 |