MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-03-19 for ACUITY H770498-SIM manufactured by Varian Medical Systems.
[4276886]
Varian was advised of potential mis-administrations at (b)(6). Based on reported information, the site uses the acuity simulator with fad 80 mode. The reports indicate the physicists did not use the field size values displayed on the acuity simulator. Instead, they increased the target areas on the linear accelerator by 20%, believing they were adjusting for divergence. This was unnecessary as the acuity automatically simulates the fad 80 technique of the varian linear accelerator. As a result, mis-administration may have occurred.
Patient Sequence No: 1, Text Type: D, B5
[11759359]
Varian is filing this mdr based on potential injuries potentially involving multiple patients. Additional follow up to this mdr is expected upon completion of the investigation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8020711-2014-00002 |
| MDR Report Key | 3720556 |
| Report Source | 08 |
| Date Received | 2014-03-19 |
| Date of Report | 2014-02-25 |
| Date of Event | 2014-01-01 |
| Date Mfgr Received | 2014-02-25 |
| Date Added to Maude | 2014-04-03 |
| 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 | K. SEMONE |
| Manufacturer Street | 911 HANSEN WAY |
| Manufacturer City | PALO ALTO CA 943041028 |
| Manufacturer Country | US |
| Manufacturer Postal | 943041028 |
| Manufacturer Phone | 6504246833 |
| 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 | 2014-03-19 |
| Model Number | H770498-SIM |
| 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 | 2014-03-19 |