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 2013-10-24 for PRECISE TREATMENT TABLE manufactured by Elekta Ltd.
[18369121]
Table lateral fault during treatment. New potentiometers were installed on the table lateral drive assembly and the table calibrated by the field service engineer. The customer was aware of the work that was done and the next morning the xvi qa scan was performed using the customer's quasar phantom. The therapist believes the scan and table shift checks passed successfully before proceeding to treat the first cone scan patient of the day. It was a bit later, after that first cone beam patient, it was noticed that the table lateral movements were not correct.
Patient Sequence No: 1, Text Type: D, B5
[18400083]
User error. The table calibration was not performed according to the instructions in the manual and the hospital qa procedures did not pick up the issue. The combination of the calibration checks defined in the manual and the hospital qa procedures are sufficient to achieve an acceptable risk level. No further improvements within the current design would reduce the risk further still. It has not been possible to estimate the magnitude of the table lateral error and hence the severity of the mistreatment for two reasons: the hospital have stated that they are unable to provide an estimate the bad calibration files were never backed up and then subsequently overwritten by the good calibration files. However, the fact that the calibration was sufficiently poor to be noticed by the hospital could indicate a large error was possible. This is the manufacturer's final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9617016-2013-00015 |
| MDR Report Key | 3426942 |
| Report Source | 00,05,06 |
| Date Received | 2013-10-24 |
| Date of Report | 2013-10-25 |
| Date Mfgr Received | 2013-10-04 |
| Date Added to Maude | 2013-10-24 |
| 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 | OT |
| 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 | 2013-10-24 |
| Operator | HEALTH PROFESSIONAL |
| 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 RH109RR UK RH10 9RR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-24 |