BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSA

    MDR report key: 10669824 · Received October 13, 2020

    Report

    Report Number
    10669824
    Event Type
    Malfunction
    Date Received
    October 13, 2020
    Date of Event
    September 8, 2020
    Report Date
    September 30, 2020
    Manufacturer
    ELEKTA LIMITED
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING TREATMENT LINEAR ACCELERATOR WAS GETTING TEMPERATURE FAULTS. AFTER TALKING TO THE ELEKTA ENGINEER IT WAS DETERMINED THAT THERE WERE FLOW ISSUES AND A CHILLER PROBLEM MAINTENANCE WAS CALLED TO INSPECT AND POWELL MECHANICAL CAME IN. THEY DISCOVERED THAT A FILTER DISLODGED AND WAS "SUCKED" INTO THE PIPE. HE BYPASSED IT AND WAS NOTIFYING THE PROJECT MANAGER TO DETERMINE IF CHILLER WAS INSTALLED INCORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1139958 VERSA ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA LIMITED VERSA

    Patients

    Seq Age Sex Outcome Treatment
    1