BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIAC CATH LAB KIT

    MDR report key: 3040417 · Received March 12, 2013

    Report

    Report Number
    2025816-2013-00004
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 10, 2012
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104989 CARDIAC CATH LAB KIT MONITORING KIT DQO ICU MEDICAL, INC. 46100-52 2572123

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown