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 2013-11-26 for PRECISE TREATMENT TABLE manufactured by Elekta Limited.
[4013061]
No actual adverse event has been reported. The customer identified that there was a 2. 5mm deviation due to isocentric rotation during routine qa. At the end of (b)(6), the site engineer was asked to inspect the system and measured a 6mm deviation using the method described in the precise table customer acceptance manual. The customer reported that treatments with isocentric rotation were rare: the one affected patient was moved to another machine. The machine continues to be used clinically with a repair planned after thanksgiving.
Patient Sequence No: 1, Text Type: D, B5
[33303702]
Root cause is suspected to be poor quality concrete surface in the shallow pit. It appears that a layer of mortar 'screed' has been appled to level the pit floor, which has subsequently crumbled around the anchor points. This is in direct contradiction of the planning guidelines. Ecr (b)(4) has been created to update the pm checks adding an isocentric check and drop test for the table. Ecr (b)(4) has been created to add extra checks for the presence of floor screeds in the pit during table installation site specific corrective action was required using a hilti epoxy to replace the screed around the floor anchors. The anchor fixing torque will be periodically monitored until confident that the compressive strength of the pit floor is adequate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9617016-2013-00017 |
| MDR Report Key | 3489273 |
| Report Source | 00,05,06 |
| Date Received | 2013-11-26 |
| Date of Report | 2014-03-07 |
| Date of Event | 2013-10-29 |
| Date Mfgr Received | 2013-10-29 |
| Date Added to Maude | 2014-03-05 |
| 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 |
| Reporter Occupation | PHYSICIST |
| 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 | 0 |
| Remedial Action | RP |
| 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 | 2013-11-26 |
| Operator | PHYSICIST |
| Device Availability | Y |
| Device Age | DA |
| 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 UK RH10 9RR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-11-26 |