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 2011-01-28 for ACUITY H77 manufactured by Varian Medical Systems, Oncology Systems.
[1934006]
Patient with 2 rtchart plans - 1st plan approved, 2nd plan (boost) not approved and planned number of fractions changed from 23 to 43. Days before starting the 2nd plan at fraction no 20, the patient was simulated again for field verification. An image folder was created inside the 1st plan and no additional changes were made. Upon opening the patient plan on the eclipse sys. The customer received a warning message and found that there were 2 plans with the same id, the former plan and the original plan. In rtchart, the customer had one plan with 43 fractions instead of 23. Upon looking closer at the rtchart editing log, there was found a treat approval for a user that had no treatment approval rights. There was no misadministration or serious injury reported associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[8843498]
Although there was no reported injury in this case, the available information suggests a malfunction of the device may have occurred. Though still under investigation, varian has determined that a mdr is appropriate as this malfunction and resulting small flame, should it recur, could potentially cause a 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 | 8020711-2010-00011 |
| MDR Report Key | 1991514 |
| Report Source | 01,05,06 |
| Date Received | 2011-01-28 |
| Date of Report | 2010-10-20 |
| Date of Event | 2010-10-20 |
| Date Mfgr Received | 2010-10-20 |
| Device Manufacturer Date | 2005-12-01 |
| Date Added to Maude | 2012-02-03 |
| 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 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACUITY |
| Generic Name | SYSTEM, STIMULATION, RADIATION THERAPY |
| Product Code | KPQ |
| Date Received | 2011-01-28 |
| Model Number | H77 |
| ID Number | VERSION EX |
| 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, ONCOLOGY SYSTEMS |
| Manufacturer Address | PALO ALTO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-01-28 |