BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COHERENCE THERAPIST

    MDR report key: 1024217 · Received March 27, 2008

    Report

    Report Number
    2910081-2008-00021
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    February 6, 2008
    Report Date
    February 29, 2008
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS
    Product Code
    IYE
    PMA / PMN Number
    K031764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    THIS INCIDENT IS BEING REPORTED IN ABUNDANCE OF CAUTION. WE HAVE BECOME AWARE OF A POTENTIAL PRODUCT ISSUE WITH OUR RECORD & VERIFY SYSTEM. WE WERE INFORMED THAT THE SYSTEM GENERATES A VERIFICATION ERROR BECAUSE THE ACTUAL TREATMENT TABLE POSITION DOES NOT MATCH THE INTENDED TARGET. DURING TESTING PHASE (NON-TREATMENT), THE INHOUSE ENGINEER IS ALLEGED TO HAVE DISCOVERED THAT THE CONTROL CONSOLE WAS AT READY STATE AND THE SYSTEM GRANTED PERMISSION TO TREAT THE FIRST SEGMENT. WHEN THE SECOND SEGMENT WAS SELECTED FOR TREATMENT, THE CONTROL CONSOLE SCREEN DISPLAYED A VERIFICATION INTERLOCK. THE INHOUSE ENGINEER STATES THAT THIS CONDITION WAS REPRODUCED TWICE. THEN THE SYSTEM EVENTUALLY "HANGS UP" AND SYSTEM REBOOT WAS NECESSARY TO RESUME OPERATION OF THE SYSTEM. THE OPERATOR COULD NOT DUPLICATE THIS ERROR CONDITION. WE HAVE NOT CONFIRMED THIS SCENARIO. THE COMPLAINT IS CURRENTLY UNDER INVESTIGATION AND THE ROOT CAUSE HAS NOT BEEN IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COHERENCE THERAPIST ACCELERATOR, LINEAR, MEDICAL IYE SIEMENS MEDICAL SOLUTIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1