MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06 report with the FDA on 2014-03-14 for APEX manufactured by Elekta Ltd.
[20270897]
The customer questions the clinical validation of elekta products with a third party frameless mask system (this rests upon the ibeam evo frameless extension). Ibeam evo frameless head and neck extension' has a much longer section (~168mm) which is the same as the width of the ibeam evo and therefore reducing the clearance. To ensure clearance with this extension and the apex, agility and xvi combination, the customer suggests that at lateral: 0. 0cm, the couch longitudinal needs to be approximately 5 ~ 7cm. The customer questions the clinical validation of elekta products with a third party frameless mask system (this rests upon the ibeam evo frameless extension). Ibeam evo frameless head and neck extension' has a much longer section (~168mm) which is the same as the width of the ibeam evo and therefore reducing the clearance. To ensure clearance with this extension and the apex, agility and xvi combination, the customer suggests that at lateral: 0. 0cm, the couch longitudinal needs to be approximately 5 ~ 7cm.
Patient Sequence No: 1, Text Type: D, B5
[20561442]
This combination has not currently been validated. Collison risk of the equipment is the most likely outcome. No patient injuries have been reported. This is the manufacturer's final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9617016-2014-00006 |
| MDR Report Key | 3679052 |
| Report Source | 00,05,06 |
| Date Received | 2014-03-14 |
| Date of Report | 2014-03-14 |
| Date of Event | 2014-02-17 |
| Date Mfgr Received | 2014-02-17 |
| Date Added to Maude | 2014-05-19 |
| 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 | PHYSICIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | LINAC HOUSE FLEMING WAY |
| Manufacturer City | CRAWLEY, WEST SUSSEX RH109RR |
| Manufacturer Country | UK |
| Manufacturer Postal | RH10 9RR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APEX |
| Generic Name | BLOCK, BEAM-SHAPING, RADIATION THERAPY |
| Product Code | IXI |
| Date Received | 2014-03-14 |
| Operator | PHYSICIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2014-03-14 |