BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 1020938 · Received March 13, 2008

    Report

    Report Number
    1225700-2008-00035
    Event Type
    Malfunction
    Date Received
    March 13, 2008
    Date of Event
    January 22, 2008
    Report Date
    February 22, 2008
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR SHOWED A DIFFERENCE IN PRESSURE BETWEEN INSPIRATORY AND EXPIRATORY PRESSURE TRANSDUCERS DURING PRE-USE CHECK AND DISPLAYING A FLOW TRANSDUCER ERROR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *