BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IC PROFILER-MR

    MDR report key: 4084960 · Received September 3, 2014

    Report

    Report Number
    1038814-2014-00001
    Event Type
    Malfunction
    Date Received
    September 3, 2014
    Date of Event
    August 6, 2014
    Report Date
    August 6, 2014
    Manufacturer
    SUN NUCLEAR CORP.
    Product Code
    LHO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE IC PROFILER-MR IS NOT USED IN THE PRESENCE OF A PATIENT. HOWEVER, STAFF SETTING UP THE IC PROFILER-MR FOR MEASUREMENT OF AN INSTALLED VIEWRAY DELIVERY SYSTEM COULD EXPERIENCE A PINCH HAZARD BETWEEN THE COVERS ON THE DELIVERY SYSTEM AND THE IC PROFILER-MR IF IT IS ATTRACTED TOWARDS THE DELIVERY SYSTEM BY THE MAGNETIC FIELD. INVESTIGATION IDENTIFIED AN ASSEMBLY ERROR OF THIS UNIT. THERE WERE 3 UNITS MANUFACTURED IN THE LOT AND 9 UNITS MANUFACTURED IN TOTAL. AS PART OF THE INVESTIGATION OF THIS INCIDENT, ALL UNITS MANUFACTURED HAVE BEEN EVALUATED. DATA OBTAINED CONFIRMED 2 UNITS CONTAINED THE ASSEMBLY ERROR. THESE UNITS HAVE BEEN REMOVED AND REPAIRED.

    Description of Event or Problem · 1

    STAFF USING AN IC PROFILER-MR AT (B)(6) RADIATION ONCOLOGY REPORTED THEIR IC PROFILER-MR UNIT THAT WAS RESTING ON THE COUCH MOVED WHEN THE COUCH WAS TRANSLATED INTO A MAGNETIC FIELD OF A VIEWRAY DELIVERY SYSTEM. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535526 IC PROFILER-MR IC PROFILER-MR LHO SUN NUCLEAR CORP. 1123 W92327

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention VIEWRAY SYSTEM