BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMRIS NEURO II-S (OR-MB)

    MDR report key: 2034653 · Received March 3, 2011

    Report

    Report Number
    3003807210-2011-00001
    Event Type
    Other
    Date Received
    March 3, 2011
    Date of Event
    January 21, 2011
    Report Date
    March 3, 2011
    Manufacturer
    IMRIS, INC.
    Product Code
    LNH
    PMA / PMN Number
    K050132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    COMPLAINT DATE: (B)(4) 2011. IMRIS WAS NOTIFIED THAT THE SPLIT ARRAY HEAD COIL HAD BEEN DROPPED AND THE IMAGING WAS POOR. INVESTIGATION COMPLETION DATE: (B)(4) 2011. THE CABLE AND CABLE TRAPS WERE PHYSICALLY DAMAGED AND BASED ON THE NATURE OF THE DAMAGE, THE CONCLUSION WAS THAT THIS PROBABLY HAPPENED OVER AN EXTENDED PERIOD OF TIME. THE DAMAGE TO THE CABLE TRAPS WAS EXTENSIVE ENOUGH TO HAVE CAUSED OPENINGS IN THE COVERS EXPOSING THE INNER CABLE TRAP. THIS DAMAGE WAS COVERED WITH TAPE, AND THE COIL APPEARS TO HAVE BEEN USED IN THIS STATE. PAGE 5 OF THE INSTRUCTIONS FOR USE REQUIRES INSPECTION PRIOR TO AND AFTER EACH USE. IN THE EVENT OF DAMAGE, THE INSTRUCTION IS TO REMOVE COIL FROM USE AND CONTACT IMRIS. NO INJURY REPORTED, HOWEVER, THIS INCIDENT HAS BEEN DETERMINED TO BE REPORTABLE AS THE USE OF A DAMAGED COIL COULD HAVE POTENTIALLY LED TO INJURY TO EITHER A PT OR USER. IMRIS HAS COMMUNICATED WITH THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMRIS NEURO II-S (OR-MB) MAGNETIC RES. IMAGING SYSTEM OR TABLE LNH IMRIS, INC. 108717-000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other NO