MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2013-04-23 for DMLC IV manufactured by Elekta Ltd..
[3351129]
This issue is concerning dmlc iv only. The angle information determines the leaf position. During engagement, the leaves of the collimator are shaped according to the current gantry position detected by the dmlc gantry sensor. The potential for incorrect readout of the gantry position was found during an internal investigation.
Patient Sequence No: 1, Text Type: D, B5
[10830306]
The risk assessment concludes an undesirable effect with respect to dmlc iv. During treatment, the leaves of the collimator are shaped according to the current gantry position detected by the dmlc gantry sensor. Incorrect readout of the gantry position can be cause of mistreatment (over or underdose). It is unk by how much the gantry position may be out. The fault may occur and persist over the majority of the beam delivery resulting in a completely static dmlc shape, or the fault may be intermittent, thus causing only a small gantry error for the rest of the treatment. The product is already end of sales and further design enhancements are not planned. A (b)(4) is being prepared for existing customers.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9617016-2013-00005 |
| MDR Report Key | 3084924 |
| Report Source | 00,07 |
| Date Received | 2013-04-23 |
| Date of Report | 2013-04-19 |
| Date of Event | 2013-03-27 |
| Date Mfgr Received | 2013-03-27 |
| Date Added to Maude | 2013-05-02 |
| 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 | 0 |
| 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 |
| Manufacturer Phone | 293654764 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DMLC IV |
| Generic Name | COLLIMATOR, ACCELERATOR, SYSTEM, MOTORIZED |
| Product Code | IXI |
| Date Received | 2013-04-23 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELEKTA LTD. |
| Manufacturer Address | LINAC HOUSE, FLEMING WAY CRAWLEY, WEST SUSSEX RH1099R UK RH10 99R |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-23 |