BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRAGER EVITA INFINITY V500

    MDR report key: 2843629 · Received October 28, 2012

    Report

    Report Number
    2843629
    Event Type
    Malfunction
    Date Received
    October 28, 2012
    Date of Event
    September 27, 2012
    Report Date
    October 25, 2012
    Manufacturer
    DRAGER MEDICAL INC
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT'S VENTILATOR TOUCHSCREEN WAS NOT WORKING. PATIENT WAS VENTILATED WITH A RESUSCITATION BAG BY RRT. THE VENT WAS CHANGED OUT AND A NEW VENT PUT IN. THE PATIENT TOLERATED WELL, THERE WAS NO ISSUE WITH THE PATIENT.MANUFACTURER RESPONSE:WAS RECENTLY UPGRADED DISPLAY, THEN HAD PROBLEMS WITH DISPLAY WHICH WAS REPLACED AS WELL AS PROBLEMS GETTING GS500 CALIBRATED WHICH WAS RESOLVED BY DRAGER TECH SUPPORT REP. VERIFIED TOUCHSCREEN CONCERNS ON THIS EVENT AND WILL CONTACT DRAGER FOR ON-SITE SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAGER EVITA INFINITY V500 VENTILATOR, CONTINUOUS, FACILITY USE CBK DRAGER MEDICAL INC EVITAINFINITYV500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR