BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2992401 · Received February 27, 2013

    Report

    Report Number
    2992401
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 27, 2013
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    MANIFOLD LEAKED AROUND CONTROL SYRINGE. NEW MANIFOLD DROPPED ONTO STERILE FIELD. EQUIPMENT REMOVED FROM STERILE FIELD. NEW STERILE MANIFOLD OPENED AND USED WITHOUT PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84173 * TRANSDUCER DRS ICU MEDICAL, INC. * 2559304

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR