MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,06 report with the FDA on 2013-08-06 for PRECISE TREATMENT TABLE manufactured by Elekta Limited.
[18310300]
The lateral movement of the precise table atm (automated table movement) was mis-calibrated in such a way that positive was changed into negative and vice versa. This allowed the displacement in the lateral axis to move in the opposite direction.
Patient Sequence No: 1, Text Type: D, B5
[18410045]
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
[34649500]
The manufacturer's investigation concluded that analysis of the site log files and calibration files showed that the lateral movement was incorrectly calibrated in the reverse direction by a hospital engineer. Since then this error passed a hospital qa check and treatments were delivered until it was spotted by a subsequent qa check. It was found that the wrong calibration procedure applied (single potentiometer as opposed to triple potentiometer) and reverse calibration values were inserted. One fraction resulted in a mistreatment. This is no clinical impact for this patient. Ifsns were released on 25th november 2013 regarding recommended quality assurance after a calibration procedure (b)(4). This is the manufacturer's final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9617016-2013-00012 |
| MDR Report Key | 3266242 |
| Report Source | 00,01,05,06 |
| Date Received | 2013-08-06 |
| Date of Report | 2013-01-17 |
| Date of Event | 2013-06-17 |
| Date Mfgr Received | 2013-07-08 |
| Date Added to Maude | 2013-10-31 |
| 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 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRECISE TREATMENT TABLE |
| Generic Name | COUCH, RADIATION THERAPY, POWERED |
| Product Code | JAI |
| Date Received | 2013-08-06 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2013-08-06 |