BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMRIS T2X OR TABLE V2 (ORT100)

    MDR report key: 7103864 · Received December 11, 2017

    Report

    Report Number
    3010326005-2017-00014
    Event Type
    Malfunction
    Date Received
    December 11, 2017
    Date of Event
    October 30, 2017
    Report Date
    December 11, 2017
    Manufacturer
    IMRIS - DEERFIELD IMAGING, INC.
    Product Code
    KXJ
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMRIS CUSTOMER SERVICE ENGINEER WAS ON SITE ON OCTOBER 31, 2017 TO DIAGNOSE THE ISSUE WITH THE OR TABLE DRIFTING IN THE ROLL POSITION. HE REPLACED THE HYDRAULIC MANIFOLD AND PERFORMED A HYDRAULIC FLUID FLUSH TO CLEAR ANY CONTAMINANTS IN THE MANIFOLD. THIS DID NOT RESOLVE THE ISSUE. ON (B)(6) HYDRAULIC FLUID FLUSH AND AIR BLEED PROCEDURES WERE PERFORMED. THIS DID NOT RESOLVE THE ISSUE; THEREFORE, THE TABLE WAS TAKEN OUT OF SERVICE UNTIL THE DRIFT ISSUE WAS RESOLVED. ON (B)(6) A NEW HYDRAULIC MANIFOLD WAS INSTALLED, TESTED THE TABLE, AND FOUND THE MANIFOLD FAULTY. HE INSTALLED A 2ND NEW MANIFOLD ON (B)(6). THE TABLE WAS TESTED AND DID NOT PASS THE DRIFT TEST. INTERNAL CAPA (B)(4) HAS BEEN ISSUED TO RESOLVE THE DRIFT ISSUE.

    Description of Event or Problem · 1

    ON (B)(6) 2017, DURING SETUP FOR A PROCEDURE AND PRE-POSITIONING THE PATIENT ON THE OPERATING ROOM (OR) TABLE, IT WAS NOTICED THAT THE OR TABLE WAS DRIFTING SLIGHTLY IN THE ROLL POSITION. THE PROCEDURE WAS MOVED TO A DIFFERENT OR SUITE. THE PATIENT DID NOT SUSTAIN ANY INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885204 IMRIS T2X OR TABLE V2 (ORT100) OPERATING ROOM TABLE, PRODUCT CODE: KXJ KXJ IMRIS - DEERFIELD IMAGING, INC. ORT100

    Patients

    Seq Age Sex Outcome Treatment
    1