BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMRIS ORT300 OPERATING ROOM TABLE

    MDR report key: 7035603 · Received November 15, 2017

    Report

    Report Number
    3010326005-2017-00012
    Event Type
    Malfunction
    Date Received
    November 15, 2017
    Date of Event
    October 30, 2017
    Report Date
    April 4, 2018
    Manufacturer
    IMRIS - DEERFIELD IMAGING, INC.
    Product Code
    KXJ
    PMA / PMN Number
    K083137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP: INVESTIGATION OF THE BACK SECTION DRIFT IDENTIFIED A BACK-TILT COUNTERBALANCE VALVE THAT EXHIBITED LEAKAGE. THE VALVE WAS REPLACED AND THE TABLE FUNCTION WAS VERIFIED BY CONDUCTING EXHAUSTIVE TESTING.

    Additional Manufacturer Narrative · 1

    (B)(4) 2017: THE HOSPITAL'S BIOMEDICAL ENGINEER PERFORMED TABLE LIFT DRIFT TESTING WITH A 40 KG LOAD OVER NIGHT - NO DRIFT WAS OBSERVED. 11/1/2017: IMRIS TECHNOLOGIST INSPECTED THE TABLE AND PERFORMED TREND AND TILT DRIFT TEST IN THE BORE OF THE MAGNET FOR 45 MINUTES. NO DRIFT WAS OBSERVED. IMRIS CLINICAL APPLICATIONS SPECIALISTS AND (B)(4) BIOMEDICAL ENGINEERING PERFORMED TABLE TILT DRIFT TESTING TWICE IN THE BORE OF THE MAGNET FOR 53 MINUTES. NO DRIFT WAS OBSERVED. 11/2 - 11/7/2017: IMRIS R&D ENGINEERING PERFORMED 6 AND 14-HOUR UNLOADED TILT DRIFT TESTING, 6 AND 14-HOUR 40 KG LOADED TILT DRIFT TESTING, 6-HOUR 200 KG LOADED LIFT/TILT DRIFT TESTING, AND INSPECTION OF HYDRAULIC LINES AFTER EACH DRIFT TEST. AFTER EXHAUSTIVE TESTING, IT WAS DETERMINED THAT THE TABLE IS MECHANICALLY SOLID WITH NO DRIFT IN THE LIFT/TREND/ROLL CYLINDERS, BUT THE BACK SECTION IS DRIFTING, SPECIFICALLY DURING THE FIRST 60 MINUTES.

    Description of Event or Problem · 1

    THIS IS A FOLLOW-UP REPORT FOR AN INCIDENT THAT OCCURRED ON (B)(6) 2017 WHERE THE CLINICAL STAFF PREPARED A (B)(6) PATIENT FOR INTRA-OPERATIVE IMAGING AND BROUGHT IN THE MAGNET OVER THE PATIENT. THEY IMAGED THE PATIENT FOR 45 MINUTES. AFTER IMAGING, WHILE RETRACTING THE MAGNET FROM OVER THE PATIENT, THEY HEARD A "CLUNK" AND THE TABLE BACK SECTION VISIBLY DROPPED/MOVED. THEY RETURNED THE MAGNET TO THE HOME POSITION. NO INJURIES WERE SUSTAINED BY THE PATIENT AND MR IMAGES WERE REPORTED TO BE GOOD. THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE CLINICAL STAFF PREPARED A SIX YEAR OLD PATIENT FOR INTRA-OPERATIVE IMAGING AND BROUGHT IN THE MAGNET OVER THE PATIENT. THEY IMAGED THE PATIENT FOR 45 MINUTES. AFTER IMAGING, WHILE RETRACTING THE MAGNET FROM OVER THE PATIENT, THEY HEARD A "CLUNK" AND THE TABLE BACK SECTION VISIBLY DROPPED/MOVED. THEY RETURNED THE MAGNET TO THE HOME POSITION. NO INJURIES WERE SUSTAINED BY THE PATIENT AND MR IMAGES WERE REPORTED TO BE GOOD. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814760 IMRIS ORT300 OPERATING ROOM TABLE RADIOLOGIC TABLE KXJ IMRIS - DEERFIELD IMAGING, INC. ORT300 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR