BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEKTA UNITY

    MDR report key: 9878524 · Received March 25, 2020

    Report

    Report Number
    9617016-2020-00001
    Event Type
    Malfunction
    Date Received
    March 25, 2020
    Date of Event
    February 25, 2020
    Report Date
    July 2, 2020
    Manufacturer
    ELEKTA LTD
    Product Code
    IYE
    PMA / PMN Number
    K192482
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CORRECTIVE ACTIONS TAKEN AS A RESULT OF INVESTIGATION IS THAT AN IMPORTANT FIELD SAFETY NOTICE (IFSN 200-01-801-008) WAS SENT TO AFFECTED CUSTOMERS ON 6TH MAY 2020. AN IMPORTANT FIELD SAFETY MODIFICATION TO INCLUDE THE INSTALLATION OF THE CORRECT CONNECTION MATERIALS AND THAT THE FIXING TORQUES ARE APPLIED WILL BE COMPLETED BY ELEKTA AND PHILIPS OVER THE NEXT 12 MONTHS.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION FOUND THAT THE PHILIPS MR GRADIENT COIL TERMINATION CABLE CONNECTORS, NUTS AND WASHERS SHOULD BE FITTED IN A SPECIFIC ORDER AND USING THE SPECIFIC MATERIALS. FAILURE TO FOLLOW THIS ORDER MAY CAUSE HIGH ELECTRICAL RESISTANCE LEADING TO EXCESSIVE HEATING OF THE CONNECTION, CABLES AND SURROUNDING AREA. THE ISSUE IS WITH THE SUPPLIED MR SYSTEM WHERE A SUPPLIER PROVIDED THE INCORRECT MATERIAL (STAINLESS STEEL NUT INSTEAD OF BRASS; CONDUCTIVITY ISSUE) AND THEN SOME SITES HAD THE CONNECTION INCORRECTLY ASSEMBLED (ORDER OF NUTS WERE INCORRECT LEADING TO POOR CONDUCTIVITY). TESTING BY THE SUPPLIER OF THE MR SYSTEM CONFIRMED THAT WHILST USING THE CURRENTLY RELEASE IMAGING PROTOCOLS THE GRADIENT COIL CONNECTION THAT IS CORRECTLY ASSEMBLED BUT WITH THE INCORRECT MATERIALS IS ACCEPTABLE FOR CLINICAL USE. SIX OF THE FOURTEEN AFFECTED SITES THAT REQUIRED IMMEDIATE INSPECTION HAD THE CONNECTION INCORRECTLY ASSEMBLED, FOUR OF WHICH WERE DAMAGED DUE TO EXCESSIVE HEAT. NO INJURIES HAVE BEEN REPORTED BY ANY SITE. IMMEDIATE CORRECTIVE ACTION WAS TAKEN ONCE THIS ISSUE WAS IDENTIFIED WHERE ALL AFFECTED SYSTEMS WERE VISUALLY INSPECTED AND IF NECESSARY, THE ASSEMBLY ORDER WAS CORRECTED BUT THE INCORRECT MATERIALS REMAINED ON THE SYSTEM.

    Description of Event or Problem · 1

    DURING ELEKTA'S INVESTIGATION OF THE MR GRADIENT COIL CONNECTION ISSUE IT WAS IDENTIFIED THAT THE GRADIENT COIL CONNECTION CAN HEAT EXCESSIVELY DUE TO A CHANGE IN CONDUCTIVITY RESULTING IN HEAT DAMAGE TO THE CABLE AND IMMEDIATE SURROUNDING AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340894 ELEKTA UNITY ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA LTD

    Patients

    Seq Age Sex Outcome Treatment
    1