BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMRIS NEURO II-S (OR-MB) ORT

    MDR report key: 1960294 · Received December 9, 2010

    Report

    Report Number
    3003807210-2010-00006
    Event Type
    Other
    Date Received
    December 9, 2010
    Date of Event
    June 25, 2010
    Report Date
    December 10, 2010
    Manufacturer
    IMRIS, INC.
    Product Code
    LNH
    PMA / PMN Number
    K050132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE CUSTOMER REPORTED THAT THE OPERATING ROOM TABLE WAS MOVING UP AND DOWN AND TILTING ON ITS OWN, WITHOUT THE MANIPULATION OF THE OPERATING ROOM TABLE PENDANT (CONTROLLER) BY THE OPERATOR. THERE WAS NO REPORT OF INJURY TO EITHER A PT OR CLINICAL STAFF. AN IMRIS CUSTOMER SUPPORT SPECIALIST INVESTIGATED THE COMPLAINT ON-SITE, BUT WAS UNABLE TO REPRODUCE THE INCIDENT. THE OPERATING ROOM TABLE PENDANT WAS LATER RETURNED TO IMRIS FOR INVESTIGATION, AND THE INCIDENT AGAIN COULD NOT BE DUPLICATED. AS THIS WAS THE FIRST OCCURRENCE, WITH NO REPORT OF INJURY AND THE INCIDENT COULD NOT BE REPRODUCED, IMRIS DETERMINED THAT THE RESULTS OF THE INVESTIGATION DID NOT WARRANT AN MDR. HOWEVER, UPON DISCOVERY OF A SECOND INCIDENT AT ANOTHER CUSTOMER SITE, IMRIS DETERMINED THAT THIS CASE SHOULD BE RE-OPENED PENDING THE CONCLUSION OF THE INVESTIGATION INTO THE ABOVE-MENTIONED CASE, AND THAT AN MDR BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMRIS NEURO II-S (OR-MB) ORT MAGNETIC RES. IMAGING SYSTEM OR TABLE LNH IMRIS, INC. 108000-000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other