BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 2120932 · Received June 2, 2011

    Report

    Report Number
    2120932
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 19, 2011
    Report Date
    June 2, 2011
    Manufacturer
    MAQUET
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    VENTILATOR PRODUCED 8-9 CENTIMETERS OF WATER (CMH2O) WHEN SET TO DELIVER 5 CMH20 POSITIVE END-EXPIRATORY PRESSURE (PEEP) CAUSING THE PATIENT TO AIR TRAP RESULTING IN AN INCREASE IN PARTIAL PRESSURE OF CARBON DIOXIDE (PCO2). PATIENT WEIGHT WAS (B)(6).======================MANUFACTURER RESPONSE FOR VENTILATOR, (BRAND NOT PROVIDED) (PER SITE REPORTER)======================SERVICE TECHNICIAN HAS SCHEDULED TO COME ON SITE FOR ANALYSIS AND SERVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *