MAUDE Adverse Event Report: MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH HEXAPOD EVO RT SYSTEM; COUCH, RADIATION THERAPY, POWERED

Model Number P10603-100

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Computer Operating System Problem (2898)

Patient Problem No Information (3190)

Event Date 01/22/2014

Event Type  No Answer Provided  

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: HEXAPOD EVO RT SYSTEM
• Type of Device: COUCH, RADIATION THERAPY, POWERED
• Manufacturer (Section D): MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH; robert-bosch-strasse 8; schwabmunchen, 8683 0; GM 86830
• Manufacturer Contact: linac house; fleming way; crawley, west sussex RH10 -9RR
• MDR Report Key: 3638591
• MDR Text Key: 3991311
• Report Number: 9710332-2014-00001
• Device Sequence Number: 1
• Product Code: JAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: P10603-100
• Device Catalogue Number: P10603-900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2014
• Initial Date FDA Received: 02/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other