BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-VIEW SYSTEM

    MDR report key: 2544934 · Received April 18, 2012

    Report

    Report Number
    3007540658-2012-00001
    Event Type
    Malfunction
    Date Received
    April 18, 2012
    Date of Event
    March 22, 2012
    Report Date
    April 18, 2012
    Manufacturer
    CARROT MEDICAL LLC
    Product Code
    DXJ
    PMA / PMN Number
    K083321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FAILURES OCCURRED AT THE FOLLOWING SITES: (B)(6). (B)(6) COMPLAINED OF REPORT THAT THE SHIELD ¿FELL¿ OFF THE C-VIEW MONITOR THIS MORNING. IT ¿BRUSHED¿ THE PATIENT ON THE WAY DOWN AND SMASHED ON THE FLOOR. NO ONE WAS HURT. (B)(6) MEDICAL CENTER COMPLAINED THAT ¿SHIELD FELL OFF THE DISPLAY. IT WAS STATED THAT THE CUSTOMER WAS MOVING THE DISPLAY BY THE SHIELD VS. THE HANDLES OR THE BEZEL.¿ (B)(6) UNIVERSITY HOSPITAL COMPLAINED THAT THE ¿SHIELD FELL OFF THE DISPLAY. A LARGE CRACK WAS CREATED DOWN THE MIDDLE AND THE BINDING CORNERS ARE ALSO CRACKED.¿ INVESTIGATION BY CARROT MEDICAL CONFIRMED THAT THE METHOD OF ATTACHING THE GLARE SHIELDS TO THE BEZEL WITH ADHESIVE IS NOT SUFFICIENT. USERS HAVE INCORRECTLY BEEN PULLING ON THE GLARE SHIELDS TO POSITION THE DISPLAY RATHER THAN THE HANDLES PROVIDED ON THE DISPLAY ITSELF. MOST GLARE SHIELDS IN THE FIELD HAVE BEEN SECURED MECHANICALLY. THE SHIELDS THAT FAILED WERE NOT SECURED MECHANICALLY, BUT RATHER ADHESIVELY. ALL THOSE SHIELDS SECURED WITH ADHESIVE ARE BEING RETROFITTED WITH A MECHANICAL ATTACHMENT METHOD. ADHESIVE IS NO LONGER USED ON NEW SYSTEMS.

    Description of Event or Problem · 1

    THREE INSTANCES OF GLARE SHIELDS COMING DETACHED FROM THE C-VIEW SYSTEM DISPLAY BEZEL HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-VIEW SYSTEM DISPLAY, CATHODE RAY DXJ CARROT MEDICAL LLC C-VIEW SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1