BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMRIS T2X OR TABLE V2 (ORT100)

    MDR report key: 12381679 · Received August 29, 2021

    Report

    Report Number
    3010326005-2021-00010
    Event Type
    Malfunction
    Date Received
    August 29, 2021
    Date of Event
    July 30, 2021
    Report Date
    August 29, 2021
    Manufacturer
    IMRIS - DEERFIELD IMAGING, INC.
    Product Code
    KXJ
    UDI-DI
    00857534006332
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER SERVICE ENGINEER OBSERVED A SMALL LEAK OF HYDRAULIC FLUID IN A PTFE HYDRAULIC FLUID RETURN HOSE IN THE CONTROL PANEL FOR THE ORT100 TABLE. THE LEAK DID NOT IMPACT FUNCTION OF THE TABLE'S HYDRAULIC SYSTEM. THE HOSE WAS OBSERVED TO HAVE SOME DAMAGE CONSISTENT WITH IT BEING IMPACTED OR SMASHED, AND A PRIOR PREVENTIVE MAINTENANCE THREE MONTHS BEFORE THIS OBSERVATION DID NOT OBSERVE ANY DAMAGED HOSES OR HYDRAULIC FLUID LEAKS. THE PTFE HOSE WAS REPLACED AND THE TABLE WAS TESTED TO VERIFY FUNCTION.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE CAUSE HAS BEEN ESTABLISHED.

    Description of Event or Problem · 1

    THE OPERATING ROOM TABLE WAS REPORTED TO BE LEAKING HYDRAULIC FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1278734 IMRIS T2X OR TABLE V2 (ORT100) OPERATING ROOM TABLE KXJ IMRIS - DEERFIELD IMAGING, INC. ORT100 00857534006332

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown