BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 9080927 · Received September 18, 2019

    Report

    Report Number
    8010042-2019-00686
    Event Type
    Malfunction
    Date Received
    September 18, 2019
    Date of Event
    August 29, 2019
    Report Date
    March 27, 2020
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K180098
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE VENTILATOR WAS INVESTIGATED BY OUR FIELD SERVICE ENGINEER (FSE). THE REPORTED STOP OF VENTILATION COULD NOT BE DUPLICATED. THE VENTILATOR PASSED FUNCTIONAL AND PRE-USE CHECKS AND WAS CLEARED FOR CLINICAL USE. NO PARTS WERE REPLACED. EVALUATION OF THE RECEIVED VENTILATOR LOGS SHOWED THAT THE VENTILATOR GENERATED A TECHNICAL ERROR CODE FOR COMMUNICATION ERROR. WHEN THIS COMMUNICATION ERROR OCCURS, VALUES AND CURVES CAN BE LOST FROM THE SCREEN DURING A MONITOR RESTART, BUT THE VENTILATOR WILL CONTINUE TO VENTILATE WITH PREVIOUS SETTINGS. THERE IS NO STOP OF VENTILATION. NO CHANGE IN SETTINGS CAN BE MADE AFTER THE ALARM OCCURS AND THE ALARMS CAN ONLY BE RESET BY DOING A SYSTEM RESTART. THE ROT CAUSE OF THE COMMUNICATION ERROR HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 0

    MANUFACTURER'S REF #: 242803

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PATIENT TREATMENT, THE VENTILATOR STOPPED. THERE WAS NO PATIENT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875407 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB SERVO-U

    Patients

    Seq Age Sex Outcome Treatment
    1