BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMRIS ORT400 OPERATING ROOM TABLE

    MDR report key: 12637520 · Received October 15, 2021

    Report

    Report Number
    3010326005-2021-00012
    Event Type
    Malfunction
    Date Received
    October 15, 2021
    Date of Event
    September 14, 2021
    Report Date
    October 14, 2021
    Manufacturer
    IMRIS - DEERFIELD IMAGING, INC.
    Product Code
    KXJ
    UDI-DI
    00857534006691
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE OF THIS EVENT WAS TRACED TO USER ERROR OF INCORRECT LOCALIZER SETTINGS; THE FIRST LOCALIZER SETTINGS WERE NOT ZEROED OUT WHICH LED TO AN ERROR IMPACTING PATIENT REGISTRATION. THE PHASE SHIFT WAS REPORTED TO BE OBSERVED PRIOR TO ABLATION THERAPY, AFTER WHICH COORDINATE ADJUSTMENTS WERE MADE AND THE PROCEDURE CONTINUED WITHOUT FURTHER IMPACT. A DEVICE MALFUNCTION WAS NOT IDENTIFIED DURING THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A MAGNETIC RESONANCE-GUIDED LITT PROCEDURE, THE AREA TARGETED FOR ABLATION APPEARED, PRIOR TO ABLATION, TO BE 4.5 MM TO 8 MM OFF TARGET. THE CASE WAS COMPLETED AFTER NOTING THE POSSIBLE IMAGE DISTORTION ISSUE AND NO PATIENT IMPACT OR CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1536275 IMRIS ORT400 OPERATING ROOM TABLE OPERATING ROOM TABLE KXJ IMRIS - DEERFIELD IMAGING, INC. ORT 400 00857534006691

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown