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 2014-02-21 for HEXAPOD EVO RT SYSTEM P10603-100 P10603-900 manufactured by Medical Intelligence Medizintechnik Gmbh.
[3991311]
Hexapod is not at load during treatment and caused possible mistreatment. The iguide was in the process of being lowered into the load position using the hand held controller, the linac was simultaneously logged out of clinical mode and put into service mode.
Patient Sequence No: 1, Text Type: D, B5
[11631887]
The manufacturer conducted an investigation. A customer reported incorrect positioning while using the hexapod evo rt couch top as a standard couch top. The customer assumed that the couch top was in its load position, however it was several millimeters above the load position. As a result, a total of three patients were incorrectly positioned. The consultant has determined that there has been no clinical significance to these patients. The manufacturer's investigation concluded: after a patient treatment the hexapod evo rt system should return the couch top to the load position. When the couch top was almost in the load position, the linac was switched into service mode. As a result, the couch top movement was immediately stopped, even though the couch top was not yet in the load position. When the linac is switched to service mode, any pending movement is cancelled. As a result, the movement pending dialogue box disappears and the movement pending leds switch off. It is a safety feature to delete any pending movement execution eg. In cases of touchguard activation. The user did not verify that the couch top was in the load position (absence of a green checkmark in the system overview means that the table is not in the load position). After the service work was completed, a total of three treatments were performed without the hexapod evo rt system. Positioning was performed by moving the precise table to a pre-defined position (table-readout). As the couch top was not in the load position, there was a difference between the target position and the actual position. It is not clear if the healthcare professional did not verify the patients position before applying radiation or if they disregarded system indications/information (deviation between laser-crosshair and table-readout). It is the radiological therapists responsibility to verify the correct patient set-up. There are some tools that support the therapist: green checkmark in the iguide system overview screen confirms the load position, room lasers, iview and xvi. The hexapod evo rt system was working as intended. A risk assessment was performed and concluded that this hazard is acceptable without further review. This is the manufacturer's final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9710332-2014-00001 |
| MDR Report Key | 3638591 |
| Report Source | 00,05,06 |
| Date Received | 2014-02-21 |
| Date of Report | 2014-02-21 |
| Date of Event | 2014-01-22 |
| Date Mfgr Received | 2014-01-23 |
| Date Added to Maude | 2014-02-21 |
| 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 | HEXAPOD EVO RT SYSTEM |
| Generic Name | COUCH, RADIATION THERAPY, POWERED |
| Product Code | JAI |
| Date Received | 2014-02-21 |
| Model Number | P10603-100 |
| Catalog Number | P10603-900 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH |
| Manufacturer Address | ROBERT-BOSCH-STRASSE 8 SCHWABMUNCHEN, 86830 GM 86830 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-02-21 |