BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART 4000

    MDR report key: 1882783 · Received October 22, 2010

    Report

    Report Number
    1218950-2010-02009
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Report Date
    September 22, 2010
    Manufacturer
    AGILENT TECHNOLOGIES, INC
    Product Code
    MKJ
    PMA / PMN Number
    K992543
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), THE CUSTOMER REPORTED AN ERROR 1000. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ERROR 1000.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART 4000 MKJ AGILENT TECHNOLOGIES, INC M5500B

    Patients

    Seq Age Sex Outcome Treatment
    1