BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMAGIQ

    MDR report key: 1220943 · Received November 4, 2008

    Report

    Report Number
    1220943
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    November 3, 2008
    Report Date
    November 4, 2008
    Manufacturer
    STILLE SURGICAL
    Product Code
    KXJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    DOCTOR FINISHING A LEFT FEMORAL POPLITEAL BYPASS, STAPLING LEG, WHEN THE FOOT OF THE TABLE STARTED DRIFTING DOWN. THE TABLE WAS LEVELED AND A STOOL WAS PLACED UNDER THE LEG TO FINISH THE PROCEDURE. PATIENT WAS UNHARMED AND UNIT WAS SENT TO BIOMEDICAL SERVICES. EXAMINATION OF TABLE FOUND THAT A HYDRAULIC HOSE FEEDING THE TREND/REVERSE TREND CYLINDER HAS BEEN DAMAGED FROM RUBBING AGAINST THE SUPPORT BLADE USED TO SUPPORT THE HOSES FEEDING THE UPPER PORTION OF THE TABLE. THE TABLE IS BEING HELD FOR INSPECTION BY MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMAGIQ IMAGING TABLE KXJ STILLE SURGICAL IMAGIQ *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR