MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2012-09-27 for ACUITY manufactured by Varian Medical Systems.
[3035567]
A pt fell off the table after radiation treatment on a different model varian medical linear accelerator. This issue was initially reported in (b)(4)/ mfr report # 2916710-2012-00026. Varian has become aware that this issue could occur on the acuity device as well. This is an internal varian complaint. No similar event/injury has been reported with the truebeam device.
Patient Sequence No: 1, Text Type: D, B5
[10192724]
Varian is reporting this mdr based on the injuries that have been reported by customers for the predicate device. Even if there is no malfunction of the device, it has been determined that acuity has the same level of risk for the type of reported events as the predicate device. The issue for the predicate device was initially reported in (b)(4) / mfr report # 2916710-2012-00026, and (b)(4), mfr report # 2916710-2012-00030. Additional f/u to this mdr is expected upon completion of the investigation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8020711-2012-00001 |
| MDR Report Key | 2773510 |
| Report Source | 00 |
| Date Received | 2012-09-27 |
| Date of Report | 2012-09-01 |
| Date of Event | 2012-09-01 |
| Date Added to Maude | 2012-10-15 |
| 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 | PETER CORONADO, DIR. |
| Manufacturer Street | 911 HANSEN WAY M/S C-260 |
| Manufacturer City | PALO ALTO CA 93404 |
| Manufacturer Country | US |
| Manufacturer Postal | 93404 |
| Manufacturer Phone | 6504246320 |
| Manufacturer G1 | VARIAN MEDICAL SYSTEMS UK LTD. |
| Manufacturer Street | GATWICK RD., CRAWLEY |
| 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 | 2012-09-27 |
| 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 | 2012-09-27 |