BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 2910118 · Received November 9, 2012

    Report

    Report Number
    8010042-2012-00135
    Event Type
    Malfunction
    Date Received
    November 9, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 12, 2012
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K062793
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY FIELD SERVICE AND THE REPORTED PROBLEM WAS NOT REPRODUCED, THEREFORE, THE DEVICE WILL NOT BE RETURNED FOR EVAL. THE DEVICE LOGS ARE BEING REVIEWED AND A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION OF THE REVIEW. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE CONNECTED TO PT, THE VENTILATOR SETTINGS STARTED DRIFTING DOWN LOW. THERE WAS NO IMPACT TO PT. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI