BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CBK

    MDR report key: 3723711 · Received March 25, 2014

    Report

    Report Number
    3008355164-2014-00064
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    February 10, 2014
    Report Date
    February 26, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR STOPPED VENTILATING WHILE IT WAS CONNECTED TO A PT. THE VENTILATOR GENERATED A TECHNICAL ERROR CODE INDICATING DISABLED VALVES FOLLOWED BY ANOTHER ONE INDICATING A DETECTED ERROR IN THE INTERNAL MEMORY. THE VENTILATOR WAS DISCONNECTED FROM THE PT AND THE PT WAS MANUALLY VENTILATED. THE VENTILATOR WAS TURNED OFF AND BACK ON AGAIN AND RECONNECTED TO THE PT UNTIL A REPLACEMENT VENTILATOR WAS BROUGHT. THE VENTILATOR WAS TAKEN TO THE BIOMED SHOP. IT PASSED THE PRE-USE CHECKS. IT WAS LEFT RUNNING ON A TEST LUNG AND THE ERROR COULD NOT BE REPRODUCED. THERE WAS NO PT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173705 CBK CBK MAQUET CRITICAL CARE AB NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI