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 2011-05-20 for ACUITY H77 manufactured by Varian Medical Systems Uk Ltd..
[15535713]
The customer reports that the "create opposing field" option doesn't properly emulate siemens units at acuity. The customer also reports that elekta units are also not properly emulated by acuity when the 'create opposing field' option is used. The customer states that they have observed this behavior since their clinical implementation of acuity in 2007, however, they have not previously reported it as they simply 'worked' around the issue by manually editing the field parameters in mosaiq. The customer states that due to staffing changes within their physics group, this behavior has been given a higher priority and they no longer want to perform the 'work around'. The customer now believes this presents a potential safety concern and reported the behavior to varian 4. 20. 2011.
Patient Sequence No: 1, Text Type: D, B5
[15865858]
Though still under investigation, varian has determined that a mdr is appropriate as this possible malfunction, should it recur, could potentially cause serious injury. Additional follow-up to this mdr is expected upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8020711-2011-00004 |
| MDR Report Key | 2111098 |
| Report Source | 01,05,06 |
| Date Received | 2011-05-20 |
| Date of Report | 2011-04-20 |
| Date of Event | 2011-04-20 |
| Date Mfgr Received | 2011-04-20 |
| Device Manufacturer Date | 2007-07-01 |
| Date Added to Maude | 2012-04-06 |
| 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, MANAGER |
| 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 | SYSTEM, SIMULATION, RADIATION THERAPY |
| Product Code | KPQ |
| Date Received | 2011-05-20 |
| Model Number | H77 |
| ID Number | 2.0.11 SP4 |
| 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 | CRAWLEY, WEST SUSSEX UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-20 |