MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-11-28 for APEX manufactured by Elekta Ltd..
[45584854]
From the results of the corrective action, apex was incorrectly fitted on to the head of the linac. The rotation of the gantry was prevented by an inhibit, but the user decided to override the inhibit and rotate the linac gantry. The apex detached from the head and hit the floor.
Patient Sequence No: 1, Text Type: N, H10
[45584855]
The customer was preparing for a patient. They thought apex was securely mounted and attempted to rotate the gantry. The system had a touch guard inhibit so the gantry would not rotate. They contacted the elekta service engineer who told them he would be there in 30 minutes. However because they were performing a 'dry run' they overrode the touch guard to inhibit to rotate the gantry. At this time the elekta engineer arrived on site. The gantry was at 300 degrees. The customer then rotated the gantry, as it passed 0 degrees rotation, the apex disengaged from the mlc and fell to the floor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617016-2012-00008 |
| MDR Report Key | 5666143 |
| Date Received | 2012-11-28 |
| Date of Report | 2012-11-22 |
| Date of Event | 2012-11-09 |
| Date Added to Maude | 2016-05-19 |
| 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 | SERVICE PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | FLEMING WAY |
| Manufacturer City | CRAWLEY |
| Manufacturer Country | UK |
| Manufacturer G1 | ELEKTA LTD. |
| Manufacturer Street | FLEMING WAY |
| Manufacturer City | CRAWLEY |
| Manufacturer Country | UK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | APEX |
| Generic Name | BLOCK, BEAM-SHAPING, RADIATION THERAPY |
| Product Code | IXI |
| Date Received | 2012-11-28 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELEKTA LTD. |
| Manufacturer Address | LINAC HOUSE, FLEMING WAY CRAWLEY, WEST SUSSEX RH109RR UK RH10 9RR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-11-28 |