BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 1834246 · Received August 30, 2010

    Report

    Report Number
    1834246
    Event Type
    Malfunction
    Date Received
    August 30, 2010
    Date of Event
    August 29, 2010
    Report Date
    August 30, 2010
    Manufacturer
    MAQUET, INC
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    VENTILATOR WAS WET. ALTHOUGH DISCONNECTED FROM PATIENT, THE VENTILATOR INDICATED A HIGH PEEP - MORE THAN 10CMH20.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *