BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMRIS ORT100 OPERATING ROOM TABLE

    MDR report key: 7663431 · Received July 5, 2018

    Report

    Report Number
    3010326005-2018-00034
    Event Type
    Malfunction
    Date Received
    July 5, 2018
    Date of Event
    June 18, 2018
    Report Date
    July 2, 2018
    Manufacturer
    DEERFIELD IMAGING, INC.
    Product Code
    KXJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE O-RING IN THE HYDRAULIC PUMP RESERVOIR HAD DEGRADED OVER TIME. THE O-RING WAS REPLACED AND THE TABLE WAS TESTED TO VERIFY PROPER FUNCTION.

    Description of Event or Problem · 1

    THE ORT100 TABLE HYDRAULIC PUMP RESERVOIR WAS LEAKING HYDRAULIC FLUID. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507606 IMRIS ORT100 OPERATING ROOM TABLE OPERATING ROOM TABLE KXJ DEERFIELD IMAGING, INC. ORT100 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1