BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 3823789 · Received February 20, 2014

    Report

    Report Number
    8010042-2014-00037
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    January 29, 2014
    Report Date
    January 30, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K062793
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER HAS BEEN ON SITE AND STARTED THE INVESTIGATION. THE REPORTED PROBLEM COULD NOT BE REPRODUCED, THEREFORE, NO PART HAS BEEN REPLACED. OUR INVESTIGATION CONSISTS ONLY OF DEVICE LOG EVAL. TEST LOGS SHOW THAT PERFORMED PRE-USE CHECK PRIOR TO AND AFTER THE REPORTED EVENT PASSED WITHOUT DEVIATION. THE REPORTED PROBLEM WAS CONFIRMED IN EVENT LOGS. THE LOGS SHOW THAT SEVERAL ALARMS WERE GENERATED DURING VENTILATION. THOSE ALARMS ARE INDICATING A HUGE LEAKAGE IN THE SYSTEM WHICH HAVE BEEN INTERPRETED AS NO RETURN VOLUME BY THE USER. THE ROOT CAUSE OF THE LEAKAGE CANNOT BE DETERMINED SINCE THE REPORTED PROBLEM COULD NOT BE REPRODUCED. ACCORDING TO RECEIVED INFO THE REPORTED VENTILATOR IS BACK IN SERVICE WITH NO MORE ISSUES REPORTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NO RETURN VOLUME DURING VENTILATION. THERE WAS NO HARM TO THE PT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106581 SERVO-I CBK MAQUET CRITICAL CARE AB NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI