BEUDAMED
    FDA Adverse Event Summary report: N

    SERVO-I

    MDR report key: 2013153 · Received February 28, 2011

    Report

    Report Number
    2013153
    Date Received
    February 28, 2011
    Date of Event
    January 17, 2011
    Report Date
    February 28, 2011
    Manufacturer
    MAQUET, INC.
    Product Code
    CBK
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    APNEA ALARM MALFUNCTION OF THE VENTILATOR. THE ALARM COULD NOT BE SET APPROPRIATELY AS THE NUMBERS WOULD "JUMP" AROUND. HOSPITAL BIOMEDICAL ENGINEERS EVALUATED ALL THREE DEVICES IN WHICH THIS MALFUNCTION WAS OBSERVED AND COULD ONLY REPRODUCE THE OBSERVED MALFUNCTION IN ONE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERVO-I SERVO I VENTILATOR CBK MAQUET, INC. * *
    2 SERVO-I VENTILATOR, CONTINOUS, FACILITY USE CBK MAQUET, INC. * *
    3 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO
    2 1 MO
    3 16 MO