MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-09-28 for ACUITY H77 manufactured by Varian Medical Systems.
[16745325]
It was reported that during a simulated single fault belt breaking or loose test condition on the exact couch, that the couch top may end up in different positon than intended.
Patient Sequence No: 1, Text Type: D, B5
[17058191]
The couch top may end up in a different positon than intended due to failures, or partial failure of mechanical components which could potentially go undetected by the feedback mechanism (i. E. The various controls/displays on the clinac would indicate couch position consistently, yet its actual position is potentially several millimeters away from its target position. This may lead to about 2. 5 mm off target treatment. While this small offset is unlikely to lead to a serious injury in normal fractionated treatments, in stereotactic radio surgery (srs) treatments in the case where the user does not use an external position verification system, it could result in unintended radiation dose to normal tissues and critical structures. Varian is not aware of any mistreatments due to this malfunction. However, it was determined this event may cause or contribute to a serious injury, if the malfunction was to recur under specific use conditions. Varian has examined device labeling and has not found any explicit warnings that external positioning systems should be used for position verification for srs treatments (although such recommendations do exist in published literature for this type of treatment). A product notification letter will be sent to affected customers. All corrective action will be reported under the guidelines of (b) (4). No follow-up reports are anticipated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916710-2009-00041 |
| MDR Report Key | 1512043 |
| Report Source | 05,06 |
| Date Received | 2009-09-28 |
| Date of Report | 2009-07-22 |
| Date of Event | 2009-04-30 |
| Device Manufacturer Date | 2002-09-01 |
| Date Added to Maude | 2010-02-02 |
| 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 | DAVE HALL, ACTING MGR |
| Manufacturer Street | 911 HANSEN WAY M/S C-255 |
| Manufacturer City | PALO ALTO CA 94304 |
| Manufacturer Country | US |
| Manufacturer Postal | 94304 |
| Manufacturer Phone | 6504833153 |
| 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 | 2009-09-28 |
| Model Number | H77 |
| ID Number | TM53391007 |
| 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 | 3100 HANSEN WAY PALO ALTO CA 94304 US 94304 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-09-28 |