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 2013-12-16 for PRECISE TREATMENT TABLE manufactured by Elekta Limited.
[3964818]
During a visit to the site to change mlc reflectors it was discovered that the iso-center table height was 2mm off. The service engineer did a quick re-calibration of the table height and checked that the height at iso-center was 0. After the weekend the customer treated 16 patients before they discovered that the table was wrongly calibrated in height and that the largest offset was 16cm. This happened because when the service engineer calibrated the table he entered the value of 500 when instead he should have entered 5000. After calibration he only checked the height at iso-centere = 0. 0 and did not tell the customer that the table height calibration was done. The customer discovered the error when the operator had to enter the room when xvi requested movement was more than 2cm. This happened (b)(6) 2013-, but elekta at that time did not realise that there had been actual mistreatments but thought the customer had discovered the fault before any mistreatment. During a visit to the site (b)(4) 2013, the service engineer was told about the mistreatments.
Patient Sequence No: 1, Text Type: D, B5
[11324752]
The investigation into this incident is on-going at this time. Once the investigation is complete, elekta will forward additional information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9617016-2013-00019 |
| MDR Report Key | 3520770 |
| Report Source | 00,05,06 |
| Date Received | 2013-12-16 |
| Date of Report | 2013-12-16 |
| Date of Event | 2013-06-03 |
| Date Mfgr Received | 2013-12-02 |
| Date Added to Maude | 2014-03-26 |
| 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 | PRECISE TREATMENT TABLE |
| Generic Name | COUCH, RADIATION THERAPY, POWERED |
| Product Code | JAI |
| Date Received | 2013-12-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELEKTA LIMITED |
| Manufacturer Address | LINAC HOUSE FLEMING WAY CRAWLEY, WEST SUSSEX RH109RR RH10 9RR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-12-16 |