BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMRIS ORT100 OPERATING ROOM TABLE

    MDR report key: 7854812 · Received September 7, 2018

    Report

    Report Number
    3010326005-2018-00037
    Event Type
    Malfunction
    Date Received
    September 7, 2018
    Date of Event
    August 9, 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
    MO, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER SERVICE ENGINEER DISCOVERED THAT THE HYDRAULIC PUMP EXHIBITED A HYDRAULIC FLUID LEAK. HE REPAIRED THE PUMP, REPLACED THE O-RING SEAL AND DAMPENING MOUNTS, AND REPLACED THE HYDRAULIC FLUID. THE TABLE WAS FUNCTIONALLY TESTED TO VERIFY PROPER FUNCTION.

    Description of Event or Problem · 0

    THE CUSTOMER STATED THAT THE ORT100 TABLE STOPPED MOVING DURING DAILY TESTING. THEY OBSERVED HYDRAULIC FLUID IN THE CONTROL PANEL OF THE TABLE. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    THE ORT100 TABLE HAS NOT YET BEEN EVALUATED. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ROOT CAUSE HAS BEEN ESTABLISHED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE ORT100 TABLE STOPPED MOVING DURING DAILY TESTING. THEY OBSERVED HYDRAULIC FLUID IN THE CONTROL PANEL OF THE TABLE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696730 IMRIS ORT100 OPERATING ROOM TABLE OPERATING ROOM TABLE KXJ DEERFIELD IMAGING, INC. ORT100 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1