MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2015-11-19 for ALIGNRT manufactured by Vision Rt Limited.
[32268762]
The investigation of the issue is still in progress.
Patient Sequence No: 1, Text Type: N, H10
[32268763]
There are no reports of any patient or user harm related to this issue. Alignrt (and gatert) can be interfaced to gate the treatment beam on siemens linacs. Whilst connected to a siemens linac, for reasons still under investigation the alignrt system may report the following warning message during a period of beam-holding due to the patient being out of position: "linac beam status is not as set. Hold the beam from the linac console. Gating has been disabled. Restart alignrt to enable gating". While the warning message is displayed and from this point onwards, the alignrt system may allow the beam on the linac to be enabled independently of the patient position. This occurred only at one customer's site. The customer confirmed that the issue was promptly identified and that no patient harm occurred. There are no reports of a similar issue having occurred at other sites.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004832819-2015-00001 |
| MDR Report Key | 5249571 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-11-19 |
| Date of Report | 2015-11-18 |
| Date of Event | 2015-10-21 |
| Date Mfgr Received | 2015-10-21 |
| Device Manufacturer Date | 2011-11-01 |
| Date Added to Maude | 2015-11-25 |
| 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 | FRANCESCO SAPIA, REF. AFFAIRS MGR. |
| Manufacturer Phone | 833257840 |
| Manufacturer G1 | VISION RT LIMITED |
| Manufacturer Street | DOVE HOUSE, ARCADIA AVE. |
| Manufacturer City | LONDON N3 2JU |
| Manufacturer Country | UK |
| Manufacturer Postal Code | N3 2JU |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ALIGNRT |
| Generic Name | PATIENT POSITIONING SYSTEM |
| Product Code | IWE |
| Date Received | 2015-11-19 |
| Model Number | ALIGNRT |
| Catalog Number | ALIGNRT |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VISION RT LIMITED |
| Manufacturer Address | LONDON UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-19 |