MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2015-07-24 for ACCURAY manufactured by Accuray Incorporated.
[42954915]
Method and materials: our investigation strategy recreated the errant treatment scenario at the mevion factory using a manufacturing equivalent couch, proposed root cause from service notes, and subsequent discussions. We tested two setup and treatment scenarios that encompass the range of possible treatment errors with the compromised couch. We measured the alignment error induced that could have gone undetected. A cube containing a laser trackable fiducial was placed on the couch top, indexed to a reference bar near the center o f the couch top (h1 index mark) and close to the position of the morning qa cube used at the site. Room lasers were previously aligned coincident with couch isocenter to better than 1mm. Conclusions: the magnitude of error observed in the incident report was outside couch sub-millimeter specifications but not above the threshold of a reportable event. The root cause of a motor mount loosened by excessive load followed by a 6-tooth slip of the gear belt is consistent with reported observations.
Patient Sequence No: 1, Text Type: N, H10
[42954916]
This report identifies a product malfunction in the accuray robocouch patient support system that we believe could result in the serious injury of a patient undergoing radiotherapy treatment. The patient treatment table, including the positioning belt, is part of an accuray premarket notification cleared medical device. No patient death or serious injury has occurred. An investigation conducted by mevion medical systems has determined it is likely the treatment table positioning belt slipped gear positions, resulting in deviation of patient setup and treatment positions from the time of slippage until the discovery of slippage and the halting of treatment. For each of the patients treated, there was a calculated deviation from the planned treatment position of less than 8mm. All patient affected by errant positioning received a single treatment fraction slightly off-target. In each case, the slippage resulted in less than an 8mm deviation from the planned position. We find, however, no basis to conclude that a recurrence of the malfunction could not result in a geometric positioning delta of greater than 10mm from the planned position, resulting in a substantial error in treatment delivery geometry, i. E. The delivered treatment geometry would not precisely meet the application parameters provided by the treatment plan. Mevion medical systems has notified accuray of the product malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007087027-2015-00001 |
| MDR Report Key | 5584559 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-07-24 |
| Date of Report | 2015-07-21 |
| Date of Event | 2015-06-11 |
| Date Mfgr Received | 2015-06-11 |
| Device Manufacturer Date | 2015-04-30 |
| Date Added to Maude | 2016-04-18 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | THOMAS FARIS |
| Manufacturer Street | 300 FOSTER ST |
| Manufacturer City | LITTLETON MA 01460 |
| Manufacturer Country | US |
| Manufacturer Postal | 01460 |
| Manufacturer Phone | 9785401500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ACCURAY |
| Generic Name | ROBOCOUCH PATIENT SUPPORT SYSTEM |
| Product Code | JAI |
| Date Received | 2015-07-24 |
| Lot Number | PTRC-003 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCURAY INCORPORATED |
| Manufacturer Address | 1310 CHESAPEAKE TERRACE SUNNYVALE CA 94089 US 94089 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-07-24 |