BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMRIS ORT100 OPERATING ROOM TABLE

    MDR report key: 8075658 · Received November 15, 2018

    Report

    Report Number
    3010326005-2018-00040
    Event Type
    Malfunction
    Date Received
    November 15, 2018
    Date of Event
    September 11, 2018
    Report Date
    November 15, 2018
    Manufacturer
    DEERFIELD IMAGING, INC.
    Product Code
    KXJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    QA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HYDRAULIC PRESSURE HOSE WAS REPLACED AND FUNCTIONALITY OF THE TABLE WAS RESTORED. THE CAUSE OF THE LEAK IN THE HOSE IS UNDETERMINABLE.

    Description of Event or Problem · 1

    THE PRESSURE HOSE INSIDE THE ORT100 TABLE WAS LEAKING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915612 IMRIS ORT100 OPERATING ROOM TABLE OPERATING ROOM TABLE KXJ DEERFIELD IMAGING, INC. ORT100 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1