BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 1162024 · Received July 8, 2008

    Report

    Report Number
    1225700-2008-00106
    Event Type
    Malfunction
    Date Received
    July 8, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 20, 2008
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT IS REPORTED THAT WHILE THE VENTILATOR WAS CONNECTED TO A PT, THE FILTER WOULD NOT ALLOW THE PT TO EXHALE, THEREBY CAUSING INCREASED PRESSURE IN THE VENTILATION CIRCUIT.

    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 *