MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-01-08 for PRECISE TABLE manufactured by Elekta Ltd..
[755615]
During pt set-up the user noticed that the readback value for longitudinal table position was in error by 8mm.
Patient Sequence No: 1, Text Type: D, B5
[8040839]
Comments: following some investigation, it was found that the potentiometer shaft on the longitudinal fine a/fine b potentiometer was loose and was the cause of inconsistent calibrations. The error was picked up through good clinical work flow. A set of tests to check this failure mode should be conducted during upgrade to versions r6. 1 or r6. 2. There is a possibility that if this set of tests are not followed, then an incorrect position could occur. No mistreatment or adverse event occurred. However, analysis of the error detection for the triple potentiometer system has concluded that an error up to 25mm (worst case estimate) is possible without detection. This demonstrates the possibility of a more serious device malfunction and potential for serious adverse event. Corrective action pending: an important notice is being prepared to alert customers to this issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9617016-2008-00002 |
| MDR Report Key | 975537 |
| Report Source | 06 |
| Date Received | 2008-01-08 |
| Date of Report | 2008-01-08 |
| Date of Event | 2007-10-30 |
| Date Mfgr Received | 2007-10-31 |
| Date Added to Maude | 2008-09-03 |
| 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 | WEST SUSSEX |
| Manufacturer City | CRAWLEY |
| 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 | 2008-01-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 980395 |
| Manufacturer | ELEKTA LTD. |
| Manufacturer Address | WEST SUSSEX CRAWLEY UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-01-08 |