MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-06-10 for PRECISE TABLE manufactured by Elekta, Ltd.
[16208616]
The investigation into this event is ongoing at this time. Further details and conclusions will be provided following the close of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[16254033]
A linac was installed and in clinical use for one year. During this time, no pts were treated using a couch rotation in their treatment plan. In 2009, two pt's required couch rotations for their treatments. One pt was treated incorrectly by 10 degrees over 19 treatments. During setup of the second pt, the staff noticed the error. No mistreatment of the second pt occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617016-2009-00003 |
| MDR Report Key | 1402168 |
| Report Source | 06 |
| Date Received | 2009-06-10 |
| Date of Report | 2009-06-10 |
| Date of Event | 2009-02-27 |
| Date Mfgr Received | 2009-04-01 |
| Date Added to Maude | 2009-06-19 |
| 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 City | CRAWLEY, WEST SUSSEX |
| Manufacturer Country | UK |
| Manufacturer Phone | 293654250 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRECISE TABLE |
| Generic Name | COUCH, RADIATION THERAPY, POWERED |
| Product Code | JAI |
| Date Received | 2009-06-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELEKTA, LTD |
| Manufacturer Address | CRAWLEY, WEST SUSSEX UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-06-10 |