BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOMOTHERAPY TREATMENT DELIVERY SYSTEM

    MDR report key: 16713087 · Received April 11, 2023

    Report

    Report Number
    3003873069-2023-00005
    Event Type
    Malfunction
    Date Received
    April 11, 2023
    Date of Event
    March 23, 2023
    Report Date
    January 9, 2024
    Manufacturer
    ACCURAY INCORPORATED
    Product Code
    IYE
    PMA / PMN Number
    K121934
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION CONCLUDED THAT THE CAUSE OF THE EVENT WAS DUE TO THE HARDWARE. IN ORDER TO RESOLVE THE ISSUE, THE CCA (COUCH CONTROL ASSEMBLY) WAS REPLACED. NO HARM WAS CAUSED TO THE PATIENT. THE RISK WAS DETERMINED TO BE ACCEPTABLE.

    Additional Manufacturer Narrative · 0

    CUSTOMER ALLEGED THERE WAS A COUCH FAULT. WHEN A PATIENT LAID DOWN ON THE COUCH, THE Z+ BUTTON WAS USED TO RAISE THE COUCH, HOWEVER, WHEN THE Z+ BUTTON WAS RELEASED, THE COUCH CONTINUED TO RAISE TO THE HIGHEST POSITION BEFORE STOPPING. THE CCK BUTTONS WOULD NOT STOP THE COUCH MOVEMENT. THIS ISSUE IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 0

    A COUCH FAULT OCCURED, THE COUCH CONTROL KEYPAD (CCK) COULD NOT STOP THE COUCH MOVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1623199 TOMOTHERAPY TREATMENT DELIVERY SYSTEM MEDICAL LINEAR ACCELERATOR IYE ACCURAY INCORPORATED H-SERIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown