BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMRIS ORT200 OPERATING ROOM TABLE

    MDR report key: 15879995 · Received November 29, 2022

    Report

    Report Number
    3010326005-2022-00016
    Event Type
    Malfunction
    Date Received
    November 29, 2022
    Date of Event
    October 26, 2022
    Report Date
    November 29, 2022
    Manufacturer
    IMRIS - DEERFIELD IMAGING, INC.
    Product Code
    KXJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER INVESTIGATED AND ADDRESSED THE REPORTED EVENT ON-SITE AFTER GAINING ACCESS TO THE OPERATING ROOM TABLE. THE TREND CYLINDER AND TWO DUAL COUNTERBALANCE VALVES WERE REPLACED WITHIN THE TABLE'S HYDRAULIC SYSTEM, AND CONFIRMED TO CORRECT THE REPORTED DRIFT IN TRENDELEBURG POSITION THROUGH SUBSEQUENT TESTING OF THE OPERATING ROOM TABLE. THE PROBABLE CAUSE FOR THE DRIFT EVENT IS HYDRAULIC FLUID LEAKAGE THROUGH THE SEALS OF THE COUNTERBALANCE VALVES IN THE HYDRAULIC MANIFOLD AND POTENTIAL DOWNSTREAM LEAKAGE THROUGH THE SEALS IN THE TREND CYLINDER. THE HYDRAULIC FLUID IN THE TABLE WAS ALSO FLUSHED DURING THE REPLACEMENT OF THE TABLE COMPONENTS. PATIENT DEMOGRAPHICS INFORMATION WAS REQUESTED BUT NOT PROVIDED BY THE CUSTOMER. INTERNAL CORRECTIVE ACTION HAS BEEN INITIATED BY THE MANUFACTURER TO FURTHER ADDRESS THIS ISSUE.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER IS ATTEMPTING TO ARRANGE A USER FACILITY VISIT THROUGH THE USER FACILITY'S THIRD PARTY SERVICER IN ORDER TO INVESTIGATE AND ADDRESS THE REPORTED DEVICE MALFUNCTION IN THE OPERATING ROOM TABLE. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A LASER ABLATION (LITT) PROCEDURE, APPROXIMATELY 9MM OF ANTERIOR TO POSTERIOR DRIFT WAS DETECTED WITHIN AN APPROXIMATELY 3 HOUR TIME INTERVAL, WHEN USING THE ORT200 OPERATING ROOM TABLE. THE CUSTOMER REPORTED ADDITIONAL SCANS WERE TAKEN AT THE SURGEON'S DISCRETION THROUGHOUT THE CASE TO ENSURE ACCURATE THERMAL MAPPING. THE CUSTOMER REPORTED THE CASE WAS COMPLETED SUCCESSFULLY AND NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2536995 IMRIS ORT200 OPERATING ROOM TABLE OPERATING ROOM TABLE KXJ IMRIS - DEERFIELD IMAGING, INC. ORT200

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other