BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XVI

    MDR report key: 3865846 · Received June 11, 2014

    Report

    Report Number
    9617016-2014-00009
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    May 12, 2014
    Report Date
    June 11, 2014
    Manufacturer
    ELEKTA LTD
    Product Code
    IYE
    PMA / PMN Number
    K100115
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS INVESTIGATED THIS CASE AND THE LOG FILES APPEAR TO INDICATE THAT AN ACTUAL MISTREATMENT OCCURRED. THE FACT THAT THE LATERAL POSITION IS IDENTICAL TO THE PREVIOUS SCAN, WHEN TAKEN IN CONJUNCTION WITH THE THERAVIEW RECORDS, WOULD APPEAR TO INDICATE THAT THE XVI TABLE LATERAL POSITION WAS FROZEN IE THE LATERAL POSITION WAS NOT BEING UPDATED AS THE TABLE WAS MOVED. IF WE ASSUME THAT THE THERAVIEW LATERAL POSITION OF 0.14 WAS CORRECT, THEN TREATMENT OCCURRED APPROX 6.5CM AWAY FROM THE CORRECT POSITION. FIELD SAFETY CORRECTIVE ACTION ((B)(4)) WAS RELEASED (B)(4) 2014 FOR DISTRIBUTION TO CUSTOMERS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED RATM UNEXPECTED TABLE MOVE. PATIENT POSSIBLY MISTREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344581 XVI ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA LTD 151341

    Patients

    Seq Age Sex Outcome Treatment
    1 Other