BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 3221163 · Received July 8, 2013

    Report

    Report Number
    8010042-2013-00110
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K062793
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    OUR FIELD SERVICE ENGINEER WAS DISPATCHED TO THE FACILITY. THE THREE DAMAGED PARTS, WHICH WERE THE CABLE, A PRINTED CIRCUIT (PC) BOARD WHOSE CONTACT WAS DAMAGED BY THE CABLE, AND THE PC GUIDE WERE REPLACED. THE SECURITY KNOB AND THE PT UNIT'S BASE WHERE IT IS SECURED WERE UNDAMAGED AND THEY WERE NOT REPLACED. IT IS STATED IN THE USER'S MANUAL THAT "BEFORE TRANSPORTING THE VENTILATOR WITH OR WITHOUT A PT CONNECTED: BE SURE THE PT UNIT AND THE USER INTERFACE PANEL ARE SECURELY ATTACHED AND LOCKED." THE ROOT CAUSE OF THE EVENT WAS THE UNSECURING OF THE PT UNIT WITH THE SECURITY KNOB. ACCORDING TO OUR RECORDS, THE VENTILATOR HAS BEEN IN USE SINCE 2010. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308889 SERVO-I CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1