BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORT200 OPERATING ROOM TABLE

    MDR report key: 4051806 · Received September 2, 2014

    Report

    Report Number
    3003807210-2014-00003
    Event Type
    Malfunction
    Date Received
    September 2, 2014
    Date of Event
    August 2, 2014
    Report Date
    September 2, 2014
    Manufacturer
    IMRIS, INC.
    Product Code
    LNH
    PMA / PMN Number
    K083137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE THREE PINS OR BOLTS THAT HOLD THE ORT200 TABLE BLOCK IN PLACE ON THE FLOOR OF THE OR. ONE OF THE PINS WENT MISSING FOR TWO WEEKS BEFORE IT WAS ACTUALLY REPORTED MISSING ON (B)(4) 2014. OR PERSONNEL ARE TRAINED TO ALWAYS ACCOUNT FOR EACH OF THE THREE PINS WHEN INSTALLING THE TABLE BLOCK, SINCE THEY ARE MADE OF FERROUS MATERIAL. WHEN THE PIN WENT MISSING, THE MR SUITE SHOULD HAVE BEEN SHUT DOWN UNTIL THE PIN WAS LOCATED; OR PERSONNEL NEGLECTED TO ACCOUNT FOR THE MISSING PIN; THEREFORE, USER ERROR CONTRIBUTED TO THIS INCIDENT. IMRIS SHALL PERFORM FURTHER INVESTIGATION TO DETERMINE IF ADDITIONAL MITIGATIONS ARE NECESSARY TO AVOID THE USE ERROR OF LEAVING FERROUS PINS IN THE SUITE. NOTE: THE 510(K) # RECORDED IS FOR THE IMRIS SYSTEM (NEURO III-SV) INSTALLED AT (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE HOSPITAL REPRESENTATIVE REPORTED THAT A PIN FROM THE ORT200 TABLE BLOCK (FREQUENTLY OPERATED BY THE CUSTOMER WHEN INSTALLING/REMOVING THE ORT200 TABLE) BECAME LOOSE AND WAS DRAWN INTO THE MAGNET, PUNCTURING THE IMAGE QUALITY PHANTOM AND THE HEADREST EXTENSION. THE EVENT OCCURRED DURING TESTING OF THE PHANTOM ON (B)(6) 2014. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533594 ORT200 OPERATING ROOM TABLE RADIOLOGIC TABLE LNH IMRIS, INC. ORT200 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1