BEUDAMED
    FDA Adverse Event Summary report: N

    HEXAPOD EVO RT SYSTEM

    MDR report key: 3638591 · Received February 21, 2014

    Report

    Report Number
    9710332-2014-00001
    Date Received
    February 21, 2014
    Date of Event
    January 22, 2014
    Report Date
    February 21, 2014
    Manufacturer
    MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH
    Product Code
    JAI
    PMA / PMN Number
    K072898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111164 HEXAPOD EVO RT SYSTEM COUCH, RADIATION THERAPY, POWERED JAI MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH P10603-100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other