BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 3251940 · Received July 24, 2013

    Report

    Report Number
    3008355164-2013-00177
    Event Type
    Malfunction
    Date Received
    July 24, 2013
    Date of Event
    July 7, 2013
    Report Date
    July 8, 2013
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT SOME POINT DURING THE MR PROCEDURE, THE VENTILATOR BEGAN ROLLING TOWARDS THE MR SCANNER AND EVENTUALLY COLLIDED WITH IT. THE FACILITY FURTHER ACKNOWLEDGED THAT THE MR VENTILATOR SAFETY PROCEDURES WERE NOT PROPERLY FOLLOWED, IN THAT THE WHEEL BRAKES WERE NOT ENGAGED, AND THE VENTILATOR MAY HAVE PASSED OVER THE GAUSS SAFETY LINE. THE HOSPITAL ALSO DOES NOT CURRENTLY USE A TETHER TO SECURE THE VENTILATOR TO A FIXED POINT IN THE ROOM. THERE WAS NO HARM TO THE PT OR TO HOSPITAL STAFF. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345640 SERVO-I CBK MAQUET CRITICAL CARE AB NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI