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 2013-10-02 for BEAM MODULATOR manufactured by Elekta Limited.
[3766009]
A physicist used a third party software to validate the leaf positions of the beam modulator and claims some of them to be more than 2mm out of position. Elekta are investigating
Patient Sequence No: 1, Text Type: D, B5
[11220246]
The investigation into this incident is on-going at this time. Once the investigation is complete, elekta will forward additional information to the fda.
Patient Sequence No: 1, Text Type: N, H10
[26163366]
This is a newly installed machine undergoing commissioning. The customer is using 3rd party software and elekta investigated the customers results. The manufacturer's investigation concluded that the root cause was a calibration error. The calibration is checked by the qa protocol used by the customer and is detectable prior to use. The system continues to meet the customer's specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9617016-2013-00014 |
| MDR Report Key | 3380380 |
| Report Source | 00,05,06 |
| Date Received | 2013-10-02 |
| Date of Report | 2014-02-14 |
| Date Mfgr Received | 2013-09-06 |
| Date Added to Maude | 2014-01-08 |
| 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 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 | BEAM MODULATOR |
| Generic Name | BLOCK, BEAM-SHAPING, RADIATION THERAPY |
| Product Code | IXI |
| Date Received | 2013-10-02 |
| Operator | PHYSICIST |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELEKTA LIMITED |
| Manufacturer Address | LINAC HOUSE FLEMMING WAY CRAWLEY, WEST SUSSEX RH109RR UK RH10 9RR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-02 |