BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMRIS ORT300 OPERATING ROOM TABLE

    MDR report key: 8447989 · Received March 25, 2019

    Report

    Report Number
    3010326005-2019-00004
    Event Type
    Malfunction
    Date Received
    March 25, 2019
    Date of Event
    March 1, 2019
    Report Date
    March 25, 2019
    Manufacturer
    DEERFIELD IMAGING, INC.
    Product Code
    KXJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER OBSERVED HYDRAULIC FLUID DRIPPING FROM THE HYDRAULIC LINE THAT RUNS TO THE PRESSURE GAUGE OF THE ORT300 TABLE. HE REPLACED THE OR TABLE HYDRAULIC LINE THAT RUNS TO THE PRESSURE GAUGE TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER SERVICE ENGINEER WAS ON-SITE TO REPAIR AN ORT300 TABLE TROLLEY. WHILE INSPECTING THE ORT300 TABLE, HE OBSERVED HYDRAULIC FLUID DRIPPING FROM THE BELLY COVER OF THE TABLE WHILE OPERATING THE HYDRAULIC PUMP. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243019 IMRIS ORT300 OPERATING ROOM TABLE OPERATING ROOM TABLE KXJ DEERFIELD IMAGING, INC. ORT300 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1