BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CBK

    MDR report key: 3474809 · Received October 17, 2013

    Report

    Report Number
    3008355164-2013-00268
    Event Type
    Malfunction
    Date Received
    October 17, 2013
    Date of Event
    September 19, 2013
    Report Date
    September 20, 2013
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON THE EVENING OF (B)(6) 2013, MRI VENTILATOR WAS IN USE ON A PT DURING AN MRI PROCEDURE. THE VENTILATOR ROLLED TOWARDS THE MRI AND THE USER INTERFACE STRUCK THE MRI. THE USER INTERFACE WENT DARK AND MADE AN ALARM SOUND. THE PT WAS UNHARMED. (B)(4). REF # MFR 8010042-2013-00196.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533456 CBK SERVO-I CBK MAQUET CRITICAL CARE AB NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI