BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALPHA OMEGA

    MDR report key: 6683773 · Received July 3, 2017

    Report

    Report Number
    9615126-2017-00001
    Event Type
    Malfunction
    Date Received
    July 3, 2017
    Date of Event
    November 30, 2016
    Report Date
    January 6, 2017
    Manufacturer
    ALPHA OMEGA ENGINEERING LTD.
    Product Code
    GZL
    PMA / PMN Number
    K123796
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO INJURY ON THE PATIENT, THE USER IMMEDIATELY REMOVED THE HEADSTAGE AND REPLACED IT WITH ANOTHER HEADSTAGE AND CONTINUED THE SURGERY PROCEDURE.

    Description of Event or Problem · 1

    THE HEADSTAGE RETURNED BACK 3 MM WHEN IT WAS CONNECTED TO MAIN UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464290 ALPHA OMEGA NEURO OMEGA HEADSTAGE GZL ALPHA OMEGA ENGINEERING LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR