BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 1994229 · Received February 11, 2011

    Report

    Report Number
    1994229
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    January 19, 2011
    Report Date
    February 11, 2011
    Manufacturer
    MAQUET, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TECHNICAL ERROR CODE 37 ON THE MAQUET SERVO-I VENTILATOR FOLLOWING SOFTWARE UPGRADE TO VERSION 5.0. THIS OCCURRED DURING THE USE OF SUCTION SUPPORT IN THE INFANT MODE. VENTILATOR SCREENS WENT BLANK AND ALARMS SOUNDED. DURING THEIR EVALUATION, HOSPITAL BIOMEDICAL ENGINEERS WERE UNABLE TO CONSISTENTLY REPRODUCE THE ERROR. THE VERSION 5.0 SOFTWARE UPGRADE WAS ADMINISTERED BY A MAQUET SERVICE TECHNICIAN APPROXIMATELY TWO MONTHS AGO IN ALL 85 VENTILATORS CURRENTLY IN USE AT THE FACILITY. THE TECHNICAL ERROR WAS PRESENTED BY FIVE OF THE 85 VENTILATORS. MAQUET HAS STATED THAT A SOFTWARE UPGRADE (VERSION 6.0) WILL BE MADE AVAILABLE AND ADMINISTERED TO ALL SERVO-I VENTILATORS CURRENTLY IN USE AT THE FACILITY BY THE END OF MARCH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 27 DAY
    2 28 DA
    3 3 MO
    4 7 MO
    5