BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYRUS ACMI DOLPHIN

    MDR report key: 1202902 · Received September 30, 2008

    Report

    Report Number
    1202902
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 30, 2008
    Manufacturer
    GYRUS MEDICAL, INC.
    Product Code
    HIH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US

    Narratives

    Description of Event or Problem · 1

    DOLPHIN HYSTEROSCOPY PUMP TUBING, INDICATED "BAD TRANSDUCER" ON DISPLAY AS IT WAS BEING SET UP ON THE PUMP PRIOR TO PROCEDURE. REMOVED FROM ROOM TO BE SENT TO COMPANY FOR EVALUATION. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYRUS ACMI DOLPHIN TUBING, HYSTEROSCOPY HIH GYRUS MEDICAL, INC. * 8147004

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR