BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS 3100B

    MDR report key: 2485497 · Received February 25, 2012

    Report

    Report Number
    2485497
    Event Type
    Malfunction
    Date Received
    February 25, 2012
    Date of Event
    February 3, 2012
    Report Date
    February 24, 2012
    Manufacturer
    CAREFUSION 2200, INC.
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    OSCILLATOR VENT SHUTDOWN ON ITS OWN AND WAS UNABLE TO RESTART. VENTILATOR WAS SWITCHED OUT WITH SPARE AND PATIENT MAINTAINED SPO2 OF 99% WHILE BEING BAGGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSORMEDICS 3100B VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION 2200, INC. 3100B *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR